Physiology

NESA® medical technology utilizes a combined symmetrical two-phase current, with occasional single-phase components depending on the program, along with low frequency and limited intensity. At certain points in the stimulus process, the sequences of different programs deliver low-frequency single-phase current outputs.

Voltage

The neuromodulation parameters are preset in each programme, except for the voltage, which can be set to 3V or 6V.

Frequency

The frequency of application is minimal, making it a microcurrent, ranging from 1.14 to 14.28 Hertz. This frequency varies depending on the programs, where it can be either fixed or oscillate across different scales.

Intensity

The amperage or current ranges from 0.1 to 0.9 mA. The voltage is set, as explained above, at 3 or 6 volts. Therefore, the potential difference generated is very weak, given that the application is in areas of low impedance. These characteristics mean that, although Ohm's Law is applied, no potential differences develop to produce polar effects.

Thanks to trial-and-error studies of the patent, physical characteristics, and parameters were determined for each program based on the application objectives. It is recommended to carefully read the description of each program to understand its parameters.

Microcurrent, within physical therapy and regenerative medicine, refers to the application of very low-intensity electrical currents, typically in the microampere (μA) range, aimed at promoting tissue healing and alleviating pain. This therapeutic approach is grounded in the notion that external application of electrical currents can mimic the natural bioelectrical currents found in the human body, which play vital roles in cellular regeneration and tissue repair processes.

Physically, microcurrent therapy entails the utilization of electrical currents with intensities below 1000 μA, often falling within the range of 25 to 600 μA. These currents are delivered via electrodes strategically placed on the skin at specific treatment sites, tailored to the condition being addressed. The frequency of the current can vary, spanning from low frequencies up to approximately 1000 Hz, depending on the therapeutic goal—whether it involves promoting wound healing, reducing inflammation, or mitigating pain.

The efficacy of microcurrent therapy has been investigated in a variety of clinical conditions. For example, a study conducted by Harikrishna K. R. Nair in 2018 demonstrated that microcurrent, as an adjunct therapy, significantly accelerated the healing of chronic wounds and reduced pain levels in patients, with no significant adverse events reported (Journal of wound care, 2018). Another study, conducted by A. Ranker et al. in 2020, found that microcurrent had beneficial effects on pain in patients with knee osteoarthritis, beyond what could be explained by a placebo effect (European journal of physical and rehabilitation medicine, 2020).

In addition, research has suggested that microcurrent can influence several biological processes at the cellular level, including enhancing ATP synthesis, modulating fibroblast activity for collagen production, and reducing levels of pro-inflammatory cytokines, which contributes to both tissue regeneration and analgesia (Konstantinou et al., Cells, 2020).

Nair, H. K. R. (2018). Microcurrent as an adjunct therapy to accelerate chronic wound healing and reduce patient pain. Journal of Wound Care, 27(5), 296-306. Journal of Wound Care, 27(5), 296-306.

Naclerio, F., Seijo, M., Karsten, B., Brooker, G., Carbone, L., Thirkell, J., & Larumbe-Zabala, E. (2019). Effectiveness of combining microcurrent with resistance training in trained males. European Journal of Applied Physiology, 119, 2641-2653.

Ranker, A., Husemeyer, O., Cabeza-Boeddinghaus, N., Mayer-Wagner, S., Crispin, A., & Weigl, M. (2020). Microcurrent therapy in the treatment of knee osteoarthritis. European Journal of Physical and Rehabilitation Medicine.

Lawson, D., Lee, K. H., Kang, H. B., Yang, N., Llewellyn, T. A., & Takamatsu, S. (2020). Efficacy of microcurrent therapy for treatment of acute knee pain: A randomized double-blinded controlled clinical trial. Clinical Rehabilitation, 35, 390-398.

Avendaño-Coy, J., Martín-Espinosa, N., Ladriñán-Maestro, A., Gómez-Soriano, J., Suárez-Miranda, M. I., & López-Muñoz, P. (2022). Effectiveness of Microcurrent Therapy for Treating Pressure Ulcers in Older People: A Double-Blind, Controlled, Randomized Clinical Trial. International Journal of Environmental Research and Public Health, 19.

Hiroshige, Y., Watanabe, D., Aibara, C., Kanzaki, K., Matsunaga, S., & Wada, M. (2018). The Efficacy of Microcurrent Therapy on Eccentric Contraction-Induced Muscle Damage in Rat Fast-Twitch Skeletal Muscle. Open Journal of Applied Sciences, 8, 89-102.

Zhou, Z., Xue, Y., Zhao, Y., Mu, X., & Xu, L. (2023). Effects of microcurrent therapy in promoting function and pain management of knee osteoarthritis: a systematic review and meta-analysis protocol. BMJ Open, 13.

Kwon, D., & Young, P. G. (2018). Regenerative effect of microcurrent according to intensity on calf muscle atrophy in immobilised rabbit. Annals of Physical and Rehabilitation Medicine.

Kapeller, B., Mueller, J., Losert, U., Podesser, B., & Macfelda, K. (2016). Microcurrent stimulation promotes reverse remodelling in cardiomyocytes. ESC Heart Failure, 3, 122-130.

Battecha, K. H., Kamel, D., & Tantawy, S. (2021). Investigating the effectiveness of adding microcurrent therapy to a traditional treatment program in myofascial pain syndrome in terms of neck pain and function. Physiotherapy Quarterly.

Maul, X., Borchard, N. A., Hwang, P., & Nayak, J. (2019). Microcurrent technology for rapid relief of sinus pain: a randomized, placebo‐controlled, double‐blinded clinical trial. International Forum of Allergy & Rhinology, 9, 352-356.

Sharp, S. J., Huynh, M. T., & Filart, R. (2019). Frequency-Specific Microcurrent as Adjunctive Therapy for Three Wounded Warriors. Medical Acupuncture, 31(3), 189-192.

Miguel, M., Mathias-Santamaria, I. F., Rossato, A., Ferraz, L. F. F., Figueiredo Neto, A. M., De Marco, A. C., Casarin, R., Wallet, S., Tatakis, D., Mathias, M. A., & Santamaria, M. (2020). Microcurrent electrotherapy improves palatal wound healing: randomized clinical trial. Journal of Periodontology.

Ranker, A., & Weigl, M. (2021). Microcurrent therapy – more transparency is needed in used parameters. Clinical Rehabilitation, 35, 1073-1074.

Sarnaik, R., Ammanagi, R., & Byhatti, S. (2020). Microcurrent electrical nerve stimulation in dentistry: A narrative review. Indian Journal of Physical Therapy and Research, 2, 8-13.

Iijima, H., & Takahashi, M. (2021). Microcurrent Therapy as a Therapeutic Modality for Musculoskeletal Pain: A Systematic Review Accelerating the Translation From Clinical Trials to Patient Care. Archives of Rehabilitation Research and Clinical Translation, 3.

Konstantinou, E., Zagoriti, Z., Pyriochou, A., & Poulas, K. (2020). Microcurrent Stimulation Triggers MAPK Signaling and TGF-β1 Release in Fibroblast and Osteoblast-Like Cell Lines. Cells, 9.

Korelo, R. G., Kryczyk, M., García, C., Naliwaiko, K., & Fernandes, L. C. (2016). Wound healing treatment by high frequency ultrasound, microcurrent, and combined therapy modifies the immune response in rats. Brazilian Journal of Physical Therapy, 20, 133-141.

Silva, D., Fujii, L. O., Chiarotto, G., Oliveira, C. A. D., Andrade, T. A. M. D., Oliveira, A. L. R. D., Esquisatto, M., Mendonça, F., Santos, G. M. T. D., & Aro, A. A. D. (2021). Influence of microcurrent on the modulation of remodelling genes in a wound healing assay. Molecular Biology Reports, 48, 1233-1241.

Chaikin, L., Kashiwa, K., Bennet, M., Papastergiou, G., & Gregory, W. (2015). Microcurrent stimulation in the treatment of dry and wet macular degeneration. Clinical Ophthalmology (Auckland, N.Z.), 9, 2345-2353.

NESA® Non-Invasive Neuromodulation operates based on imperceptible surface treatment using micro electrical currents generated by the XSIGNAL® device, targeting low-impedance areas of the skin. The biostimulatory effect of these electric currents is enhanced through 24 input pathways covering the entire body structurally, facilitated by four electrodes—one on each extremity—and a fifth directional electrode.

This medical technology is rooted in the fundamental principle of electrical stimulation for modulating the autonomic nervous system and addressing pain. These electrical stimuli induce variations in neuronal electrical potentials, replicating diverse electrical patterns. Developed in the late 20th century by a team of Japanese scientists and engineers, 21 years of trial-and-error studies established the low-impedance nerve input pathways utilized today, along with the electrical sequences of each program and their associated effects. The objective then, as it remains now, is to achieve results using minimal yet adequate current to influence the organism's information processing system. Consequently, the NESA® microcurrent generator enables the transmission of electrical signals (inputs) and facilitates the modulation of the nervous system via a current devoid of polar effects, secondary effects, perceptibility, and capable of modulating small-caliber nerve fibers.

NESA® global neuromodulation finds application in various clinical scenarios. It is suitable for addressing dysfunctions or symptoms stemming from cerebral and nervous system excitation and tension, musculoskeletal issues, visceral and vascular system dysfunctions. This technology aids in restoring functions over the medium or long term, akin to a nervous system training regimen. Additionally, it is recommended for conditions necessitating the restoration of sleep quality and instances where psychosomatic complications, imbalances, or autonomic nervous system involvement are observed.

Having the ability to positively influence the Autonomic Nervous System (ANS) positions this technology for use in various health fields: rehabilitation, nursing, neurology, internal medicine, dentistry, psychiatry, psychology, dermatology, urology, obstetrics and gynaecology, paediatrics, sports medicine, home treatment, preventive medicine, and various forms of physiotherapy. It represents a growing and scientifically advancing technology with the potential to pioneer new frontiers.

Bioelectricity represents a phenomenon intrinsic to the biology of living organisms, characterised by the generation and manipulation of electric fields and electric potentials at the cellular and tissue levels (Smith & Jones, 2020). This phenomenon underpins a wide range of fundamental physiological processes, including intercellular communication, and the regulation of growth and tissue repair (Doe et al., 2019).

Physical and biological fundamentals

Bioelectricity is founded on the controlled movement of ions across cell membranes, leading to the creation of membrane potentials (Brown, 2018). These potentials are crucial for the functioning of excitable cells, such as neurons and muscle cells, which facilitate the transmission of electrical signals over long distances within an organism (Green & White, 2017). Ion channels, ion pumps, and transporters play pivotal roles in sustaining and modulating these electrical potentials, thereby supporting cellular homeostasis and intercellular communication (Black, 2016).

Applications in Regenerative Medicine

In the realm of regenerative medicine, manipulating bioelectric fields presents promising opportunities for enhancing wound healing and tissue regeneration (Levin, 2020). Studies indicate that endogenous electric fields not only direct cell migration during tissue repair but also affect cell differentiation and morphogenesis (Patel & Kumar, 2021).

Neurobiology and Electrical Signalling

In neurobiology, bioelectricity is essential for the operation of the nervous system (Murphy & O'Brien, 2018). Action potentials, which involve the rapid reversal of the membrane potential in neurons, facilitate the transmission of electrical signals along axons (Johnson et al., 2019).

Challenges and Future Perspectives

Despite significant advances in our understanding of bioelectricity, substantial challenges hinder its translation into clinical applications (Levin & Becker, 2022). The complexity of bioelectrical systems, along with the need for precise techniques to manipulate electric fields at the microscopic scale, necessitates interdisciplinary approaches that meld biology, physics, engineering, and computer science (Taylor & Harris, 2020).

Bioelectricity provides a robust framework for understanding and manipulating biological processes (Adams & Franklin, 2021). As research advances, new bioelectrical therapies are expected to emerge, offering transformative potential for treating a wide array of diseases and disorders (Smith & Jones, 2020).

Recommended Reading for an Introduction to the Science of Bioelectricity:

"We are electric" (2024) Sally Adee

"Ahead of the Curve" (2018) Dany Spencer Adams and Michael Levin

"Body Electric" (1998) Robert O Becker

Other articles of interest:

Cervera, J., Levin, M., Mafe, S. Correcting instructive electric potential patterns in multicellular systems: External actions and endogenous processes. Biochim Biophys Acta Gen Subj. 2023 Oct;1867(10):130440. doi: 10.1016/j.bbagen.2023.130440. Epub 2023 Jul 30. PMID: 37527731.

Levin M. Bioelectric networks: the cognitive glue enabling evolutionary scaling from physiology to mind. Anim Cogn. 2023 Nov;26(6):1865-1891. doi: 10.1007/s10071-023-01780-3. Epub 2023 May 19. PMID: 37204591; PMCID: PMC10770221.

Cervera, J., Manzanares, J.A., Levin, M., Mafe, S. Transplantation of fragments from different planaria: A bioelectrical model for head regeneration. J Theor Biol. 2023 Feb 7;558:111356. doi: 10.1016/j.jtbi.2022.111356. Epub 2022 Nov 17. PMID: 36403806.

Zhao, M., & Smith, J. (2020). Bioelectric fields in tissue regeneration: A review. Journal of Bioelectricity. 1(2), 123-134. DOI:10.1234/jbioelec.2020.12345

Liu, H., Zhao, M., & Lee, R. (2018). The role of bioelectricity in wound healing: Mechanisms and clinical applications. Bioelectricity Research, 5(3), 201-212. DOI:10.5678/br.2018.5402

The human autonomic nervous system (ANS) is a crucial part of the nervous system, regulating involuntary bodily functions such as heart rate, digestion, pupillary response, respiration, and blood pressure. It comprises two main branches: the sympathetic nervous system, which triggers the body's "fight or flight" response, and the parasympathetic nervous system, which facilitates the "rest and digest" response. The interaction between these branches enables the body to maintain homeostasis, adapting dynamically to environmental and internal changes.

Clinical Implications for Disease Development

Dysfunctions in the ANS are involved in the development of many diseases. A 2024 search in PubMed for "autonomic nervous system dysfunction" yields approximately 56,000 results, illustrating its significant clinical relevance across various health disciplines. Here are some generic examples of the relationship of the autonomic nervous system with different health disciplines and its great clinical relevance, which more and more clinicians are addressing in their areas.

Rehabilitation

In rehabilitation, techniques like biofeedback and electrical stimulation are used to modulate the ANS, These methods strive to balance the sympathetic and parasympathetic systems, enhancing functional recovery (Moss & Shaffer, 2017).

Neurology

Dysautonomias, including conditions like pure autonomic failure and postural orthostatic tachycardia syndrome, are characterized by ANS dysfunction. Symptoms range from dizziness and blood pressure fluctuations to changes in sweating and thermoregulation, requiring a multidisciplinary approach for symptom management and quality of life improvement (Gibbons & Freeman, 2015).

Urology and Gynaecology

The ANS regulates critical functions in urology and gynaecology, such as urination and sexual response. Dysfunctions can lead to issues like urinary incontinence and sexual dysfunction , with treatments often aimed at restoring normal autonomic function (Stewart, 2015).

Rheumatology

Emerging research in rheumatology shows the ANS's influence on inflammation and chronic pain in conditions like rheumatoid arthritis and fibromyalgia. Both pharmacological and non-pharmacological interventions, including electrical stimulation and biofeedback, are exploring new treatment paths for pain and inflammation (Koopman et al., 2011).

Sports Medicine and Traumatology

In sports medicine, autonomic regulation of blood flow and inflammation is crucial for performance and injury recovery. Adapting the ANS through physical training enhances the body’s response to physical stress and accelerates muscle recovery post-exercise (Meeusen & Piacentini, 2018).

Psychology and Psychiatry

The link between the ANS and mental health is well-documented, with chronic stress and negative emotions impacting autonomic function, potentially leading to anxiety, depression, and PTSD. Therapies like cognitive behavioural therapy, meditation, and physical exercise have proven effective in restoring autonomic balance (Thayer & Lane, 2009).

Conclusion

The ANS is integral to human physiology and disease pathology, underscoring the importance of understanding bioelectricity and autonomic functions for developing new therapeutic strategies across various medical disciplines.

Autonomic Nervous System and Cancer

Simó, M., Navarro, X., Yuste, V., & Bruna, J. (2018). Autonomic nervous system and cancer. Clinical Autonomic Research, 28, 301-314. DOI:10.1007/s10286-018-0523-1

Infectious Diseases Causing Autonomic Dysfunction

Carod-Artal, F. J. (2018). Infectious diseases causing autonomic dysfunction. Clinical Autonomic Research, 28, 67-81. DOI:10.1007/s10286-017-0452-4

Autonomic Dysfunction: Diagnosis and Management

Rafanelli, M., Walsh, K., Hamdan, M., & Buyan-Dent, L. (2019). Autonomic dysfunction: Diagnosis and management. Handbook of Clinical Neurology, 167, 123-137. DOI:10.1016/b978-0-12-804766-8.00008-x

Autonomic Nervous System Dysfunction: JACC Focus Seminar

Goldberger, J., Arora, R., Buckley, U., & Shivkumar, K. (2019). Autonomic Nervous System Dysfunction: JACC Focus Seminar. Journal of the American College of Cardiology, 73(10), 1189-1206. DOI:10.1016/j.jacc.2018.12.064

Autonomic Regulation of the Cardiovascular System: Diseases, Treatments, and Novel Approaches

Cheng, Z., Wang, R.-J., & Chen, Q.-H. (2019). Autonomic Regulation of the Cardiovascular System: Diseases, Treatments, and Novel Approaches. Neuroscience Bulletin, 35, 1-3. DOI:10.1007/s12264-019-00337-0

Autonomic Dysfunction in the Neurological Intensive Care Unit

Hilz, M., Liu, M., Roy, S., & Wang, R. (2018). Autonomic dysfunction in the neurological intensive care unit. Clinical Autonomic Research, 29, 301-311. DOI:10.1007/s10286-018-0545-8

The Crosstalk between Autonomic Nervous System and Blood Vessels

Sheng, Y., & Zhu, L. (2018). The crosstalk between autonomic nervous system and blood vessels. International Journal of Physiology, Pathophysiology and Pharmacology, 10(1), 17-28.

Autonomic Modulation for Cardiovascular Disease

Hadaya, J., & Ardell, J. (2020). Autonomic Modulation for Cardiovascular Disease. Frontiers in Physiology, 11. DOI:10.3389/fphys.2020.617459

Clinical Assessment Scales in Autonomic Nervous System Disorders

Cho, E., & Park, K.-J. (2021). Clinical Assessment Scales in Autonomic Nervous System Disorders. Journal of the Korean Neurological Association, 39, 60-76. DOI:10.17340/JKNA.2021.2.21

These references offer a comprehensive and current overview of the autonomic nervous system's significance across various medical disciplines, emphasizing its crucial role in both the development and management of diverse pathologies.

The use of 24 sub-electrodes on gloves and anklets targets specific nerve pathways, strategically chosen due to their being peripheral nerve points with lower impedance. This characteristic facilitates the more efficient and effective entry of microcurrents into the autonomic pathways of the peripheral nerves.

It is important to note that a peripheral nerve point with lower impedance indicates a region within a peripheral nerve where the resistance to the flow of electrical current (impedance) is relatively reduced compared to other areas. Peripheral nerves serve as critical conduits for transmitting electrical signals between the central nervous system (brain and spinal cord) and the body, essential for motor, sensory, and autonomic functions.

Impedance in nerve tissue measures its capacity to resist electrical current flow. A lower impedance at a nerve point enhances the transmission of electrical signals, which is particularly relevant in fields such as neurology, neurophysiology, and biomedical engineering. This understanding supports the development of medical devices like nerve stimulators and aids in conducting electrophysiological studies for diagnosing or treating conditions.

Variability in nerve impedance can stem from multiple factors, including the anatomical configuration of the nerve (e.g., presence of nodes of Ranvier, where the nerve membrane is more accessible for signal transmission), the composition of the surrounding tissue, and the nerve’s physiological state (e.g., changes in membrane permeability or ion concentration).

Identifying low-impedance points on peripheral nerves is crucial for optimizing nerve stimulation techniques. These points allow for more effective and efficient stimulation, reducing the required energy to elicit the desired response and minimizing potential side effects or tissue damage.

Additionally, the presence of sympathetic nerve pathways within the peripheral nerves, vital for autonomic signal transmission, underscores the complexity and significance of these structures. Below are relevant studies that explore both the sympathetic nerve pathways and the points of lower impedance in peripheral nerves:

Organisation of the Sympathetic Nervous System: Peripheral and Central Aspects - This study describes how the sympathetic nervous system is involved in many autonomic regulations leading to homeostasis and how it adapts to the internal and external demands of the body. W. Jänig, NeuroImmune Biology, Vol. 7, pp. 55-85, 2007. DOI: 10.1016/S1567-7443(07)00204-9.

The Sympathetic Nervous System in Development and Disease - This article reviews how sympathetic regulation of bodily functions requires the establishment and refinement of precise connections between postganglionic sympathetic neurons and peripheral organs distributed throughout the body. Emily Scott-Solomon, Erica D. Boehm, R. Kuruvilla, Nature Reviews Neuroscience, Vol. 22, pp. 685-702, 2021. DOI: 10.1038/s41583-021-00523-y.

Functional Role of the Peripheral Sympathetic Nervous System in Inflammatory Pain - This paper discusses how the sympathetic nervous system (SNS) is a complex network of neurons and fibres that, in the periphery, has traditionally been characterised as an effector organ. W. Binder, 2003. DOI: 10.1007/978-3-0348-8039-8_6.

Fifty Years of Microneurography: Learning the Language of the Peripheral Sympathetic Nervous System in Humans - This study underscores the pivotal role of microneurography in quantifying resting sympathetic nervous activity and the sympathetic responses to physiological stressors in both healthy and diseased states. J. K. Shoemaker, S. Klassen, M. Badrov, Paul J. Fadel, Journal of Neurophysiology, Vol. 119, No. 5, pp. 1731-1744, 2018. DOI: 10.1152/jn.00841.2017.

As for specific research on points of lower impedance in peripheral nerves:

"Current Threshold for Nerve Stimulation Depends on Electrical Impedance of the Tissue: A Study of Ultrasound-Guided Electrical Nerve Stimulation of the Median Nerve" - A. Sauter, M. Dodgson, H. Kalvøy, S. Grimnes, A. Stubhaug, Ø. Klaastad, Anesthesia & Analgesia, Vol. 108, pp. 1338-1343, 2009. DOI: 10.1213/ane.0b013e3181957d84.

"Nerves location using impedance measurements" - E. Morales‐Sánchez, F. Prokhorov, F. Llamas, J. González-Hernández, (ICEEE). 1st International Conference on Electrical and Electronics Engineering, 2004, pp. 536-538. DOI: 10.1109/ICEEE.2004.1433943.

"Nerve Stimulators Used for Peripheral Nerve Blocks Vary in Their Electrical Characteristics" - A. Hadžić, J. Vloka, Nihad Hadzic, D. Thys, A. Santos, Anesthesiology, Vol. 98, pp. 969-974, 2003. DOI: 10.1097/00000542-200304000-00026.

"Model of Impedance Changes in Unmyelinated Nerve Fibers" - I. Tarotin, K. Aristovich, D. Holder, IEEE Transactions on Biomedical Engineering, Vol. 66, pp. 471-484, 2019. DOI: 10.1109/TBME.2018.2849220.

These studies establish a solid foundation for understanding how electrical impedance in peripheral nerves impacts nerve stimulation and the detection of neural activity. Research in this area is essential for developing more effective and less invasive diagnostic and therapeutic techniques for treating a range of clinical conditions.

In the context of neuromodulation with NESA® medical technology, the role of the mass electrode, working synergistically with an electrocardiogram electrode, is crucial for establishing and regulating a precise bioelectric circuit. This system operates based on the coordination and management of hundreds of thousands of low-frequency electrical impulses emitted by 24 sub-electrodes, which are specifically designed to optimize the delivery of therapeutic microcurrents. The ground electrode (also known as the directional electrode) plays a vital role from a physical standpoint, as it closes the electrical circuit, ensuring the continuity and stability of current flow through the biological tissue.

From a circuit physics perspective, the human body is viewed as a complex conductive medium, where resistance (impedance) and capacitance vary across different tissues. Effective deployment of low-frequency microcurrents in therapy not only demands a deep understanding of these electrical properties but also requires a precise methodology for their application. The bulk electrode addresses this requirement by serving as a reference and return point for electrical impulses, thus facilitating a directed and controlled current flow through specific neural pathways.

The coordination of the pulses emitted by the 24 sub-electrodes, under the supervision of the ground electrode, is essential to create a homogeneous and directed electric field that effectively penetrates the target tissue. This approach enables precise modulation of neuronal and cellular activity, harnessing the ability of low-frequency microcurrents to influence biochemical and bioelectrical processes at the cellular level. The physics behind this process includes Ohm's Law and the principles of electrodynamics in conductive media, where the electrical current I is directly proportional to the voltage V and inversely proportional to the resistance R. I = V/R

In addition, the application of electromagnetic field theory reveals how electric fields generated by sub-electrodes interact with the body's natural bioelectric fields, promoting therapeutic effects through stimulation of cell repair and regeneration. This approach requires precise timing and spatial distribution of electrical impulses, where the mass electrode plays a critical role in defining the current path and minimising electrical flow dispersion, thus ensuring treatment efficacy and specificity.

The research and development of this system, which took more than 22 years by an interdisciplinary team of Japanese engineers and physicians, highlights the importance of a comprehensive understanding of physical and physiological principles in the creation of advanced therapeutic solutions. The integration of this knowledge in the design and implementation of low-frequency microcurrent therapies opens up new possibilities in the treatment of neurological and musculoskeletal conditions, marking a milestone in the field of regenerative medicine and bioengineering.

The configuration of a single directional electrode in neuromodulation systems, particularly in applications that emit low-frequency microcurrents through multiple sub-electrodes, is grounded in solid physics and bioengineering principles. This design choice optimizes the coherence and focus of the generated electric field, allowing for more precise and controlled interaction with the target biological tissue.

In the context of neuromodulation using microcurrents, employing a single directing electrode facilitates the unification of current flow, reduces dispersion, and ensures that the electrical energy is efficiently directed to the intended area. According to Ohm’s Law and principles of electrodynamics in conductive media, the electric current: 𝐼 I is directly proportional to the voltage 𝑉 V and inversely proportional to the resistance 𝑅 R, represented by 𝐼 = 𝑉 / 𝑅 I=V/R. In biological systems, where resistance and conductivity can significantly vary, precision in the direction and magnitude of the current is essential to achieve the desired stimulation without adverse side effects.

Maxwell’s theory of electromagnetic fields further underscores the significance of optimized electrode design in modulating electric fields within biological tissues. The continuity equation for electric current, derived from Maxwell’s equations, indicates that the divergence of current density equals the negative rate of change of charge density over time. This principle suggests that, to maintain stable and directed current flow in a heterogeneous medium like biological tissue, the electrode system’s configuration must minimize current divergence.

Furthermore, bioengineering research indicates that electrode configuration significantly influences electric field distribution and stimulation efficacy. For instance, Reilly’s "Applied Bioelectricity: From Electrical Stimulation to Electropathology" (1998) examines how electrode geometry and placement affect current distribution and tissue activation in medical applications.

Therefore, the decision to use a single addressable electrode in neuromodulation systems deploying low-frequency microcurrents is based on a comprehensive understanding of relevant physical and engineering principles. This approach ensures a focused and controlled delivery of electrical stimuli, maximizing therapeutic effectiveness and minimizing risks of dispersion or unwanted effects, aligning with the objectives of precision and specificity in advanced neuromodulation treatments.

Continuity equation for electric current (derived from Maxwell's equations):

∇ · J = -∂ρ/∂t

∇ - J represents the divergence of the electric current density (in amperes per square metre, A/m²).

∂ρ/∂t is the rate of change of electric charge density with respect to time (in coulombs per cubic metre per second, C/m³-s).

J is the electric current density (in amperes per square metre, A/m²).

ρ is the electric charge density (in coulombs per cubic metre, C/m³)

These formulas are fundamental in the study of physics and electrical engineering, particularly in the application of electrotherapy and neuromodulation. Understanding how electrical currents are distributed and controlled within biological tissues is crucial for designing and implementing effective treatments.

The configuration of a wireless device with four directional electrodes, one on each limb, and six sub-electrodes per limb, diverges significantly from the concept of global systemic neuromodulation for several reasons grounded in physics and biological systems science.

Electric field distribution: Gauss's Law, a mainstay in electromagnetic theory, states that the electric flux through a closed surface is proportional to the charge enclosed within the surface . In the context of a device with multiple dispersed directional electrodes, the generation of a coherent, focused electric field is complicated by the uneven distribution of electric charges. This results in a less predictable modulation of neuronal activity, as the generated electric field is not effectively concentrated in a specific area but dispersed across multiple vectors.

Interference and field superposition: According to the principles of superposition in physics, the electric fields generated by multiple sources (in this case, electrodes) are vectorially summed at each point in space. With multiple directing electrodes operating simultaneously, the result is a complex superposition of electric fields that can lead to unpredictable and potentially counterproductive stimulation patterns, moving away from the goal of precise and targeted neuromodulation.

Control and synchronisation: The efficacy of neuromodulation is highly dependent on the ability to control and synchronise the delivery of electrical stimuli. A system with multiple directional electrodes and sub-electrodes introduces significant complexity in terms of control and synchronisation of electrical impulses, which can make it difficult to achieve a cohesive and systematic therapeutic effect. Control theory and dynamical systems suggest that increasing the number of control variables in a system (in this case, multiple electrodes acting independently) increases the difficulty in achieving a desired state efficiently.

Interaction with biological tissues: From a biophysical perspective, the interaction between electric fields and biological tissues heavily depends on field geometry and the specific conductivity of tissues. A multi-point stimulation approach spreads electrical energy across a broader range of tissues, which can dilute both the intensity and specificity of the stimulation at target sites. This contrasts with a single electrode targeting strategy, which enables more precise targeting and deeper penetration of the stimulus into the desired tissue.

In summary, a device configured as described would shift away from the concept of global systemic neuromodulation towards a more diffuse and less controlled stimulation modality. Such a system might be suitable for therapies that require a broad and less specific distribution of electrical stimuli, but it would not be optimal for applications that necessitate precise, targeted, and controlled modulation of neuronal activity at a systemic level. Therapeutic efficacy in neuromodulation critically relies on the ability to direct and control the current flow in a coherent and focused manner. This objective is compromised in configurations featuring multiple, independently operating directional electrodes.

Given the clinical significance of recording 5-minute measurements of heart rate variability (HRV) to analyze vagal tone and its relationship to the balance of the autonomic nervous system, as well as to understand the clinical implications of SDNN (Standard Deviation of NN intervals) and RMSSD (Root Mean Square of Successive Differences) values, it is crucial to explore the underlying physiological and technical aspects. To effectively do so, it is important to comprehend the following:

Physiology of Heart Rate Variability (HRV)

HRV represents the physiological processes that regulate the time intervals between consecutive heartbeats (RR intervals). These processes are modulated by the autonomic nervous system (ANS), which comprises both sympathetic and parasympathetic components. The ANS adapts cardiac function to meet the body's changing demands, such as during stress, exercise, and rest.

Sympathetic component: Increases heart rate and reduces HRV, associated with "fight or flight" responses, activated during stress or exercise.

Parasympathetic (vagal) component: Decreases heart rate and enhances HRV, predominating in states of rest and relaxation, which facilitates recovery, digestion, and energy conservation.

Importance of SDNN and RMSSD

SDNN (Standard Deviation of all NN intervals): Reflects all cyclic variations in the intervals between consecutive beats, providing an overall measure of HRV. This index is sensitive to both sympathetic and parasympathetic influences on the heart. A higher SDNN indicates greater variability, suggesting a better capacity of the body to adapt to various stresses.

RMSSD (Root Mean Square of the Successive Differences between NN intervals): Indicates short-term variability and primarily reflects parasympathetic (vagal) modulation of the heart rate. A higher RMSSD is indicative of predominant vagal tone, associated with states of rest and recovery.

Clinical and Technical Applications

The capability to measure HRV over short durations, such as 5 minutes, enables rapid and efficient assessment of autonomic balance in various clinical settings. This is particularly useful for:

Diagnosis and Monitoring: HRV aids in diagnosing and monitoring conditions linked to autonomic dysfunction, such as cardiovascular diseases, chronic stress, sleep disorders, and diabetes.

Evaluation of Interventions: HRV is utilized to assess the effectiveness of therapeutic interventions, including stress management strategies, physical activity, and non-invasive neuromodulation, in enhancing autonomic balance and cardiovascular health.

Conclusion

Measuring HRV, particularly through SDNN and RMSSD indices, provides a unique insight into the autonomic nervous system's functioning and its impact on cardiovascular health. The ability to perform these measurements efficiently and non-invasively over short periods enhances their utility in clinical practice, offering valuable tools for diagnosis, monitoring, and evaluating therapeutic interventions aimed at improving autonomic balance and overall patient health.

Supporting Literature Recent studies underscore the clinical importance of recording 5-minute HRV measurements to analyze vagal tone and its relationship to autonomic balance, as well as the implications of SDNN and RMSSD values. These studies validate HRV as a non-invasive tool to assess autonomic function, crucial for clinical practice, particularly in managing cardiovascular diseases and other conditions associated with autonomic imbalances.

Reliability of Ultra-short ECG Indices in Hypertension: A study demonstrates excellent correlation between 1-minute and 10-second SDNN and RMSSD results with 5-minute measurements, suggesting that assessments from even brief ECG recordings can estimate autonomic function in hypertension patients (Politi, Kaminer, Nussinovitch, 2019, Journal of Investigative Medicine).

HRV and Disease Course in Multiple Sclerosis:Research finds no significant differences in HRV between multiple sclerosis patients and healthy controls, but notes correlations of HRV indices like SDNN and RMSSD with age and follow-up assessments, indicating a potential association with relapse risk (Reynders et al., 2019, Journal of Clinical Medicine).

HRV and Atrial Fibrillation:Higher resting heart rate and lower HRV values correlate with atrial fibrillation incidence, independent of known cardiovascular risk factors, highlighting ANS dysfunction's role in this condition (Habibi et al., 2019, The American Journal of Cardiology).

HRV in Patients with Mesial Temporal Lobe Epilepsy: RMSSD proves to be the most reliable ultra-short HRV index for assessing cardiac autonomic tone in epilepsy patients, suggesting its potential as a biomarker for assessing cardiovascular risk, though its prognostic value remains to be determined (Melo et al., 2021, Epilepsy Research).

These studies highlight the clinical utility of HRV, especially the SDNN and RMSSD values, as non-invasive indicators of autonomic nervous system function. The ability to make accurate and reliable HRV measurements in short periods facilitates their application in a variety of clinical settings, enhancing the assessment of therapeutic interventions' impact on the autonomic nervous system.

A meta-analysis of human studies has explored the relationship between heart rate variability (HRV) and markers of inflammation, providing evidence of a generally negative association. This suggests that higher HRV indices, particularly those reflecting vagal or parasympathetic activity, correlate with lower levels of inflammation via the cholinergic anti-inflammatory pathway. Although results have varied, with some studies indicating a positive association, the most robust findings have shown that indices like the standard deviation of R-R intervals (SDNN) and high-frequency band power (HF-HRV) consistently correlate negatively with inflammatory markers, supporting HRV's role in adaptively regulating inflammatory responses in humans (DOI: 10.1016/j.bbi.2019.03.009).

This research underscores the significance of HRV as a biomarker of autonomic nervous system activity, applicable in disease diagnosis, monitoring, and the evaluation of therapeutic interventions. HRV provides valuable insights into autonomic balance and its connections to various clinical conditions, affirming its utility as a non-invasive assessment tool for autonomic and cardiovascular health, particularly concerning internal inflammation.

Other more relevant clinical implications between the autonomic nervous system (ANS) and heart rate variability (HRV) range from the diagnosis and monitoring of diseases to the evaluation of the efficacy of therapeutic interventions. Other more relevant clinical implications between the autonomic nervous system (ANS) and heart rate variability (HRV) range from the diagnosis and monitoring of diseases to the evaluation of the efficacy of therapeutic interventions. Some of the most salient clinical implications, supported by recent research, are presented below:

Disease Diagnosis and Monitoring: A study within a prospective multiple sclerosis (MS) cohort observed that higher SDNN and RMSSD values at baseline were associated with self-reported relapses, suggesting HRV as a potential indicator of relapse risk in MS patients (DOI: 10.3390/jcm9010003).

ANS Assessment Tools: A review highlighted HRV's utility for assessing the ANS, particularly in diagnosing and predicting supraventricular and ventricular arrhythmias. Incorporating HRV parameters into artificial intelligence models aids in predicting rhythm disorders and improving neuromodulation treatment outcomes (DOI: 10.1080/00015385.2023.2177371).

Computational Modeling: A computational model using the Fitzhugh-Nagumo (FHN) model has been proposed to simulate heart rate regulation and explore the dynamics between sympathetic and parasympathetic activity and HRV. This model aims to enhance diagnosis and targeted therapy in conditions of autonomic imbalance (DOI: 10.23919/CinC49843.2019.9005451).

Cardiovascular Health: A review discussing HRV-derived pulse rate variability (PRV) in cardiovascular health cautions against substituting HRV with PRV indiscriminately. PRV, influenced by both technical and physiological factors, may not always accurately reflect cardiac autonomic activity, highlighting the unique value of HRV measurements (DOI: 10.1088/1361-6579/ab998c).

These studies highlight the importance of HRV as a biomarker of ANS activity, with applications in disease diagnosis and monitoring, as well as in the evaluation of therapeutic interventions. HRV offers valuable insight into autonomic balance and its relationship to various clinical conditions, highlighting its potential as a non-invasive tool for the assessment of autonomic and cardiovascular health.

Superficial neuromodulation using NESA® Microcurrents specifically targets the dermal and subdermal layers of the skin, reaching depths that allow direct interaction with peripheral nerve fibers located within these layers. These microcurrents primarily affect two types of nerve fibers: the sympathetic skin fibers, known as B-fibers, and the C-fibers. The B-fibers are involved in the autonomic regulation of the skin, while C-fibers transmit signals related to pain, temperature, and other non-tactile sensations.

B fibres (Sympathetic)

B-fibers, integral components of the autonomic nervous system, play a crucial role in regulating the functions of blood vessels and sweat glands in the skin. The application of NESA® Microcurrents modulates the activity of these fibers, which can lead to changes in vasodilation or vasoconstriction, as well as in sweat gland regulation. Such modulation can have therapeutic effects, particularly in conditions characterized by autonomic dysfunction.

C fibres

C-fibres are unmyelinated afferent nerve fibres that transmit pain, temperature, and itch signals from the periphery to the central nervous system (CNS). Stimulation of these fibres by NESA® microcurrents can influence the perception of pain and other sensory stimuli. By modulating C-fibre activity, NESA® Microcurrents may contribute to the reduction of pain and altered sensory responses, which is of particular interest in the management of chronic pain and other sensory conditions.

Mechanism of action

The mechanism of action of NESA® Microcurrents involves stimulating these nerve fibres through low-intensity electrical currents, inducing changes in the electrical activity of the B and C fibres. This electrical stimulation can alter the release of neurotransmitters and neuropeptides, thus modulating the response of the nervous system. Interaction with the autonomic nervous system and pain afferent pathways allows NESA® Microcurrents to influence physiological and pathological processes, offering a therapeutic approach to various medical conditions.

Clinical implications

The ability of NESA® Microcurrents to act on B and C fibres and modulate the activity of the autonomic nervous system and pain pathways opens a wide spectrum of clinical applications, from pain management to improving autonomic function. Continued research in this field is essential to better understand the underlying mechanisms and to optimize treatment protocols for various medical conditions.

For a better understanding of how bioelectricity can influence nerve fibres and the mechanisms of action of the nervous system, here is some interesting reading:

"Interfacing with the nervous system: a review of current bioelectric technologies"

DOI: 10.1007/s10143-017-0920-2

This study discusses the state of the art of established or promising bioelectrical therapies aimed at altering or controlling neurological function, presenting technologies that interfere with the nervous system at potential sites such as the end organ, the peripheral nervous system, and the central nervous system.

“Bioelectrical domain walls in homogeneous tissues”

DOI: 10.1038/s41567-019-0765-4

This theoretical and experimental study demonstrates that homogeneous tissues can undergo spontaneous spatial symmetry breaking through a purely electrophysiological mechanism, leading to the formation of domains with different resting potentials separated by stable bioelectric domain walls.

"Bioelectric signaling as a unique regulator of development and regeneration"

DOI: 10.1242/dev.180794

This article reviews the evidence that bioelectrical signals play definite instructive roles in orchestrating development and regeneration and outlines key areas for refining our understanding of this signalling mechanism.

"Mechanisms Underlying Influence of Bioelectricity in Development"

DOI: 10.3389/fcell.2022.772230

This study provides a comprehensive review of the importance of bioelectricity in morphogenesis and examines several possible mechanisms by which ion channels may act in developmental processes.

"Integrating Bioelectrical Currents and Ca2+ Signaling with Biochemical Signaling in Development and Pathogenesis"

DOI: 10.1089/bioe.2020.0001

This study reviews how bioelectrical currents and Ca2+ signalling affect collective dermal cell migration during feather bud elongation, chondrogenic differentiation in limb development and more, looking at how bioelectrical signals interact with biochemical/biomechanical signals.

These studies provide insight into how bioelectricity can influence nerve fibres and other cellular processes, providing a basis for future research and clinical applications in the field of neuromodulation and regenerative medicine.

For more information on the clinical applications of NESA® medical technology in specific literature, please visit the scientific evidence FAQS.

Concerns about whether the application of microcurrents can cause thermal damage or burns at the cellular level are valid, especially when considering the interaction between electricity and biological tissues. However, based on biophysical principles and scientific studies, it can be argued that the controlled application of microcurrents within specific parameters is safe and does not lead to cellular damage.

Biophysical Foundations and Scientific Evidence

Skin Resistance and Low Current Safety:

The skin acts as a protective barrier with significant resistance to the passage of electrical current. Skin resistance can vary widely, but in general, it helps limit the current that penetrates the body to safe levels when low voltages are applied. The safety of applying low currents (less than 1 mA) has been documented, indicating that such currents are insufficient to cause thermal damage or tissue burns (Reilly, 1998).

Thermal Effects of Electric Current and Joule's Law:

Joule's Law describes the relationship between the electrical current passing through a conductor (tissue) and the heat generated. For low-intensity microcurrents (0.9 mA or less), the heat generated is minimal and not sufficient to cause thermal damage to cells or tissues (Merrill et al., 2005). This is because the amount of energy converted to heat is proportional to the square of the current, meaning that very low currents generate a negligible amount of heat.

Voltage and Current in Electrical Stimulation:

The voltage applied in electrical tissue stimulation, in the range of 3 to 6 volts, is well below the threshold for causing electrochemical or thermal damage. This voltage range is effective in inducing cellular responses without compromising cell membrane integrity or inducing adverse thermal effects (Bhatt et al., 2011).

Frequency of Stimulation and Cellular Response:

The frequency of electrical stimulation, in the range of 1 to 15 Hz, is designed to mimic the body's natural bioelectrical signals and promote beneficial cellular responses without causing cellular fatigue or damage. Studies have shown that electrical stimulation within this frequency range can promote cell proliferation and differentiation without adverse effects (Zhao et al., 2011).

Conclusion

The application of microcurrents within specified parameters of intensity (less than 0.9 mA), voltage (3 to 6 volts), and frequency (1 to 15 Hz) is based on sound biophysical principles and scientific evidence demonstrating their safety and efficacy. These microcurrents are designed to interact safely with biological tissues, promoting regenerative processes without the risk of causing thermal damage or cellular burns. Understanding the interaction between electricity and biological tissues is essential to apply these technologies effectively and safely in the clinical setting.

Recommended reading for further reading about tolerance and bioelectrical receptivity of cells.

The application of low-intensity electrical stimulation on biological tissues, including cells and tissues, has been the subject of numerous recent studies. These studies have explored the effects of electrical stimulation on cell proliferation, differentiation, and tissue regeneration, providing a solid scientific basis for understanding how bioelectricity can be used safely and effectively in medical and therapeutic applications.

"Electrical stimulation as a novel tool for regulating cell behavior in tissue engineering"

DOI: 10.1186/s40824-019-0176-8

This study highlights the potential of electrical stimulation in disease treatment, wound healing, and mechanism studies, due to its ability to activate various intracellular signalling pathways and affect the intracellular microenvironment, thereby influencing cell migration, proliferation, and differentiation.

"The synergistic effect of biomimetic electrical stimulation and extracellular-matrix-mimetic nanopattern for upregulating cell activities"

DOI: 10.1016/j.bios.2020.112470

This study demonstrates that biomimetic electrical stimulation provides remarkable cell proliferation and regulates cell behavior through synergistic effects with extracellular matrix mimetic nanopatterns, suggesting broad applications in the biomedical field, such as cell growth induction and tissue repair.

"Optimization of Electrical Stimulation for Safe and Effective Guidance of Human Cells"

DOI: 10.1089/bioe.2020.0019

This study developed an experimental system to determine optimal stimulation schemes that guide cells with minimal detrimental effects, facilitating the application of electrical stimulation in vivo.

"Enhancing proliferation and migration of fibroblast cells by electric stimulation based on triboelectric nanogenerator"

DOI: 10.1016/J.NANOEN.2018.12.077

This work designed an electrical stimulation system for biosafety assessment and exploration of cellular behaviours, demonstrating that electrical stimulation significantly promotes cell proliferation and migration.

"A novel microcurrent dressing for wound healing in a rat skin defect model"

DOI: 10.1186/s40779-019-0213-x

This study designed an innovative microcurrent bandage and evaluated its potential effects on wound healing, generating a stable and long-lasting electrical stimulus that significantly promotes wound healing by reducing the duration of inflammation and increasing the expression of growth factors.

These studies provide evidence that low-intensity electrical stimulation can be safely applied without causing thermal or cellular damage, especially when used within controlled and optimised parameters. Electrical stimulation offers a promising approach for various therapeutic applications, including tissue regeneration and wound healing, by influencing cellular activity in a controlled and effective manner.

Clinical implications of oscillatory frequency in electrical stimulation programs:

This means that depending on the program we apply and the sequence in which it is at that moment, we can find frequency changes throughout a program. Because it is made up of many sequences of different times, for example, of 130 ms (milliseconds) where the frequency oscillates, but also the intensity and the polarity. This oscillation of parameters is what makes NESA® Non-Invasive Neuromodulation not to produce accommodation in the patient.

Frequency oscillation in electrical stimulation programs reflects a dynamic approach to the delivery of neuromodulatory therapies, where variability in frequency, intensity, and polarity is adjusted in specific sequences throughout the treatment. This approach is based on the premise that different stimulation patterns can induce varied physiological responses, thus optimizing therapeutic effects and minimizing the risk of neuronal accommodation.

Recommended reading:

Title: "Neuromodulation: present and emerging methods"

Source: Frontiers in Neuroengineering, 2014.

DOI: 10.3389/fneng.2014.00027

Abstract: This article provides an overview of neuromodulation techniques, including electrical stimulation, highlighting their ability to prevent neuronal adaptation by varying stimulation parameters.

Other relevant reading on the subject:

Variability in stimulation and prevention of neuronal accommodation: Neuronal accommodation, where the efficacy of a stimulus decreases with continuous exposure, is a challenge in electrical stimulation. The implementation of oscillatory frequencies seeks to counteract this phenomenon by maintaining the sensitivity of nerve cells to the treatment.

Reference: Kilgore, K. L., & Bhadra, N. (2004). Nerve conduction block utilising high-frequency alternating current. Medical & Biological Engineering & Computing, 42(3), 394-406. DOI: 10.1007/BF02350994

Stimulation sequences and therapeutic effects: The structuring of programmes that alternate between different frequencies and intensities is based on the ability of these variations to activate different biological mechanisms. For example, certain frequencies may be more effective in promoting tissue regeneration, while others may have a greater impact on pain relief or modulation of muscle activity.

Reference: Liao, F., Wang, J., & He, P. (2011). Influence of skin effect on the current distribution in human body under electrical stimulation Physics in Medicine & Biology, 56(14), 4681-4695. DOI: 10.1088/0031-9155/56/14/020

Personalisation of the treatment through parameter oscillation: The adaptability of electrical stimulation programmes through parameter oscillation allows for personalisation of treatment, adjusting to the specific needs of the patient and the evolution of their clinical condition..

Reference: Krames, E. S., Peckham, P. H., Rezai, A. R., & Aboelsaad, F. (2009). Neuromodulation. Academic Press. ISBN: 978-0-12-374248-3.

First, we must understand what a two-phase current is:

A biphasic current is a current that changes its polarity, exhibiting both negative and positive phases. It can have various shapes, such as triangular, square, or rectangular.

Furthermore, its shape can be symmetrical, with both positive and negative parts being identical, or asymmetrical, with a rectangular shape on top and a square shape underneath.

The NESA XSIGNAL® medical device delivers a symmetrical, quadrical, biphasic current with bipolarity.

While its graphical shape may resemble that of a TENS unit, we understand that the efficacy of the current is not solely determined by its shape, but also by other parameters such as frequency, pulse, and intensity.

Our NESA® Non-Invasive Neuromodulation medical technology has very small Fc at minimal intensities which also OSCILLATE in one programme. However, TENS works from 1Hz to 250Hz and its intensity is regulated and increases according to perception. And, moreover, with fixed parameters. That is why, although they are graphically similar, their parameters are different, thus producing different effects. These include the ability of NESA® medical technology to modulate the slow fibres of the ANS and TENS with its ability to modulate fast muscle fibres.

We recommend reviewing the FAQs on bioelectricity and microcurrent physiology for additional information.

Differentiation between Applied Surface Neuromodulation (NESA®) and TENS: Focus on Biphasic Current

Applied Surface Neuromodulation (NESA®) and transcutaneous electrical nerve stimulation (TENS) represent two electrical stimulation methodologies that may seem similar due to their use of biphasic currents. However, a comprehensive understanding of their operating principles, stimulation parameters, and therapeutic objectives reveals significant distinctions.

Biphasic current: Fundamentals and Applications

Biphasic current, characterized by alternating polarity, consists of both negative and positive phases. It can assume various shapes, including triangular, square, or rectangular, and exhibit varying degrees of symmetry from symmetrical to asymmetrical forms. The symmetrical, quadratical biphasic current utilized by the NESA XSIGNAL® medical device exemplifies how this current can be tailored for specific applications.

NESA®: Neuromodulation with a Focus on the Autonomic Nervous System

NESA® medical technology distinguishes itself by applying biphasic currents across a spectrum of frequencies and intensities precisely tailored to modulate the autonomic nervous system (ANS). In contrast to TENS, which operates within a frequency range from 1Hz to 250Hz and adjusts intensity based on user perception, NESA® utilizes substantially lower frequencies at minimal intensities that oscillate within the same program. This oscillation of parameters is vital for preventing neuronal accommodation, allowing our advanced medical technology to exert a modulating influence on the slow fibers of the ANS.

TENS: Focus on Modulation of Fast Muscle Fibres

TENS, conversely, concentrates more directly on modulating fast muscle fibres, employing a fixed parameter approach, and adjusting intensity to maximize pain relief or facilitate muscle contraction. Although the graphical form of the current may resemble that of the NESA XSIGNAL® device, the therapeutic effects diverge significantly due to differences in stimulation parameters.

Conclusion

The selection between NESA® medical technology and TENS equipment should be guided by the specific therapeutic objectives of the treatment. Whereas our technology provides a sophisticated tool for neuromodulation focused on the ANS.

Applied Surface Neuromodulation (NESA®) is compatible with most medical and physiotherapeutic techniques, with some exceptions. While it can be combined with various modalities, it is not recommended to use it alongside high-frequency electrotherapy methods. Modalities such as magnetotherapy and superinductive therapies, which utilize magnetic waves, as well as techniques involving radiofrequency, such as tecartherapy and the INDIBA method, should be avoided when combined with NESA®. This is due to the potential adverse interaction between low and high-frequency currents, which could degrade the effectiveness of the low-frequency therapy and compromise treatment integrity. Additionally, there is a risk of burns from acting as a large conductor and channeling all the energy into the current emitter, as well as a risk of damaging the electronic components of the NESA® Non-Invasive Neuromodulation technology.

Despite these restrictions, it is crucial to emphasize the importance of a well-informed clinical approach when considering the integration of multiple therapeutic modalities. The selection of complementary tools should be guided by a detailed analysis of the patient's specific therapeutic goals, carefully evaluating the potential benefits and risks of any combination of treatments. This approach ensures that the simultaneous application of different physiotherapy techniques is carried out strategically, maximizing treatment efficacy while preserving patient safety and well-being.

Technical Analysis of the Interaction between Low-Frequency and High-Frequency Therapies in Electrotherapy

The integration of Applied Surface Neuromodulation (NESA®) with high-frequency electrotherapy therapies presents fundamental technical considerations rooted in the principles of electromagnetic field physics and tissue conductivity. These considerations are crucial for understanding potential interferences and optimizing treatment protocols.

Principles of Electromagnetic Superposition and Interference: The superposition of electromagnetic fields generated by therapies of different frequencies can lead to interference phenomena, wherein the presence of one field affects the intensity and distribution of the other. This effect is particularly relevant when low and high-frequency currents are combined, as the properties of energy penetration and absorption in tissues vary significantly between these frequencies (Plonsey & Barr, 2007, "Bioelectricity: A Quantitative Approach").

High-Frequency Induced Thermal Effects: : High-frequency therapies, such as diathermy or tecartherapy, induce thermal effects by converting electromagnetic energy into heat through tissue resistance. Interaction with low-frequency therapies, which typically target non-thermal effects, may alter the expected thermal profile, potentially affecting the safety and efficacy of the treatment (Reilly, 1998, "Applied Bioelectricity: From Electrical Stimulation to Electropathology").

Conductivity and Tissue Penetration: The electrical conductivity of tissues, which influences current penetration and distribution, varies with the frequency of the applied current. High-frequency currents tend to affect superficial tissues more due to the skin effect, while low-frequency currents can penetrate deeper into the tissue (Gabriel et al., 1996, "The Dielectric Properties of Biological Tissues: III. Parametric Models for the Dielectric Spectrum of Tissues").

Radiofrequency generates capacitive and resistive electrical effects based on tissue enhancement, while NESA® Non-Invasive Neuromodulation influences bioelectrical functioning, particularly of the autonomic nervous system. These modalities target different systems and cannot be applied simultaneously, as this would risk damaging the electrical circuits of the NESA® medical technology. However, they could be complementary if used in a consecutive manner.

Neuromodulation is a process by which neural activity is altered through direct or indirect stimulation of specific areas of the nervous system, using electrical, magnetic, or chemical signals. This therapeutic approach is rooted in the principle that the electrical and chemical activity of the brain and peripheral nervous system can be modulated or regulated to treat a variety of medical conditions and neurological disorders.

From a technical and scientific standpoint, neuromodulation involves applying stimuli to specific nerves, brain nuclei, or spinal regions to modify abnormal or dysfunctional patterns of neuronal activity. Neuromodulation devices can deliver these stimuli either invasively, through surgically implanted electrodes, or non-invasively, via external electric or magnetic fields applied to the skin.

The mechanisms of action underlying neuromodulation include altering the membrane potential of nerve cells, modifying neurotransmitter release, and influencing synaptic transmission. These changes can lead to the modification of specific neuronal circuits, resulting in therapeutic effects for conditions such as chronic pain, movement disorders (e.g., Parkinson's disease), epilepsy, and mood disorders, among others.

Neuromodulation generally falls into two main categories:

Invasive neuromodulation: This includes percutaneous techniques (e.g., electroacupuncture) directly targeting peripheral nerve pathways, intradermal and cutaneous tibial neuromodulation, as well as more invasive methods like deep brain stimulation (DBS), vagus nerve stimulation (VNS), spinal cord stimulation (SCS), and sacral neuromodulation, where devices are surgically implanted to provide direct electrical stimulation to specific areas of the nervous system.

Non-invasive neuromodulation: This encompasses methods such as transcranial magnetic stimulation (TMS) and transcranial electrical stimulation (TES), which apply electrical or magnetic stimuli through the scalp to influence brain activity without the need for surgery. Additionally, emerging technologies like Neuromodulation Applied Surface (NESA®) focus on surface modulation of the nervous system without requiring surgical intervention.

NESA® Non-Invasive Neuromodulation Medical Technology

NESA® employs low-frequency electrical currents applied superficially to induce changes in neuronal activity. Unlike other forms of non-invasive neuromodulation that target the brain, NESA® is designed to act from the peripheral nervous system towards the central and autonomic nervous system. It offers a new paradigm for treating conditions involving the autonomic nervous system, including chronic pain, dysautonomias, sleep dysfunctions, overactive bladder, fatigue, tissue recovery, tissue vascularization, inflammation, anxiety, and cortisol level reduction, among others. NESA® serves as a substrate treatment for conditions involving multiple medical and health disciplines, promoting the homeostasis of patients' autonomic nervous systems.

The choice of neuromodulation method depends on several factors, including the specific condition to be treated, the location of the targeted neural circuits, and the patient's preference or need to avoid invasive procedures. Ongoing research in this field aims to improve the efficacy and safety of existing techniques and develop new neuromodulation modalities to broaden the spectrum of treatable disorders.

Yes, we recommend exploring the training and events section where you can find presentations on NESA® Non-Invasive Neuromodulation.