Efficacy of Non-invasive Neuromodulation NESA Through Somatosensory Evoked Potentials and Sympathetic-cutaneous Responses in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Response speed of the central and peripheral nervous system to a stimulus 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people
- •Optimal cognitive abilities and mentally competent to participate in the study.
- •In condition to complete the study questionnaires.
排除标准
- •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
结局指标
主要结局
Response speed of the central and peripheral nervous system to a stimulus 1
时间窗: Up to 1 month
The Somatosensory Evoked Potentials of both median and ulnar nerves will be evaluated. Neurophysiological tests of the nervous system that functionally assesses the nerve pathways of the central and peripheral nervous system. For its evaluation, distal stimuli are generated in the wrists in the range of 3-4Hz with intensities above the sensitive threshold and below the pain threshold.
次要结局
- Response speed of the central and peripheral nervous system to a stimulus 2(Up to 1 month)
- Response speed of the central and peripheral nervous system to a stimulus 3(Up to 1 month)
- Response speed to sensitive stimuli in the palms of the hand and sole of the feet(Up to 1 month)
研究者
Aníbal Báez Suárez
Principal Investigator
University of Las Palmas de Gran Canaria