Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses

Официальное название

Efficacy of Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses in Healthy Subjects

Обзор

Somatosensory evoked potentials are crucial in determining the physiological changes of potentials in nerve pathways. Although their main function is diagnostic, the investigators have recently been used as a physiological test to determine physioelectric changes in healthy subjects to study applied stimuli, such as laser, pain or electrotherapy.

Подробное описание

The general configuration of the study consists of a study before and after the block of sessions to be determined, and differences of all the variables measured before and after NESA therapy will be compared through the mechanisms of somatosensory evocations.

Given its potential use, the objective of this study is to determine if there are changes in the somatosensory evoked potentials of the ulnar, median, tibial, peroneal and vagus nerves when non-invasive neuromodulation NESA is applied, which is used as a physiotherapy treatment. for objectives such as pain, vegetative affectations and sleep disorders.

The variables of the study will be collected at two time points: before the intervention and at the end of the intervention.

The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p \<0.05

Вмешательства

• Устройство Non-invasive Neuromodulation
  The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA.

Первичные конечные точки

• Response speed of the central and peripheral nervous system to a stimulus 1 [Срок оценки: Up to 1 month]

Вторичные конечные точки (3)

• Response speed of the central and peripheral nervous system to a stimulus 2 [Срок оценки: Up to 1 month]
• Response speed of the central and peripheral nervous system to a stimulus 3 [Срок оценки: Up to 1 month]
• Response speed to sensitive stimuli in the palms of the hand and sole of the feet [Срок оценки: Up to 1 month]

Критерии участия

Критерии включения

• Healthy people
• Optimal cognitive abilities and mentally competent to participate in the study.
• In condition to complete the study questionnaires.

Критерии исключения

• Focal mononeuropathies in both upper and lower limbs
• Peripheral neuropathy.
• Patients with implanted functioning pacemakers / defibrillators. Patients with bleeding disorders. Patients being treated with anticoagulants. Patients on antiplatelet therapy.
• Present some of the contraindications for a treatment with NESA XSIGNAL®: pacemakers, internal bleeding, do not apply electrodes on skin in bad condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and / or electricity phobia.
• Not having signed the informed consent.
• Present any injury or pathology during the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Cheshire WP, Freeman R, Gibbons CH, Cortelli P, Wenning GK, Hilz MJ, Spies JM, Lipp A, Sandroni P, Wada N, Mano A, Ah Kim H, Kimpinski K, Iodice V, Idiaquez J, Thaisetthawatkul P, Coon EA, Low PA, Singer W. Electrodiagnostic assessment of the autonomic nervous system: A consensus statement endorsed by the American Autonomic Society, American Academy of Neurology, and the International Federation o PMID 33419664
• Cruccu G, Aminoff MJ, Curio G, Guerit JM, Kakigi R, Mauguiere F, Rossini PM, Treede RD, Garcia-Larrea L. Recommendations for the clinical use of somatosensory-evoked potentials. Clin Neurophysiol. 2008 Aug;119(8):1705-1719. doi: 10.1016/j.clinph.2008.03.016. Epub 2008 May 16. PMID 18486546
• Fallgatter AJ, Neuhauser B, Herrmann MJ, Ehlis AC, Wagener A, Scheuerpflug P, Reiners K, Riederer P. Far field potentials from the brain stem after transcutaneous vagus nerve stimulation. J Neural Transm (Vienna). 2003 Dec;110(12):1437-43. doi: 10.1007/s00702-003-0087-6. Epub 2003 Jan 1. PMID 14666414
• Usami K, Kawai K, Sonoo M, Saito N. Scalp-recorded evoked potentials as a marker for afferent nerve impulse in clinical vagus nerve stimulation. Brain Stimul. 2013 Jul;6(4):615-23. doi: 10.1016/j.brs.2012.09.007. Epub 2012 Oct 11. PMID 23088852

Идентификаторы

NCT: NCT04962737 · NESAJaen

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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