The Effects of a TENS System (Transcutaneous Electric Nerve Stimulation) on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis (ENNOX Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Changes in oxyhemoglobin level at baseline and at week 2.
研究概览
简要总结
Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). Sustained contractile activity, such as that observed in spastic muscles, could reduce the capillary density and induce important changes in the muscular microcirculation, leading to oxidative changes within the muscular tissue. Such changes reflect altered aerobic metabolism and impaired mitochondrial function. The available therapeutic strategies for treating spasticity and related symptoms are usually faced with limited efficacy and numerous side effects. For these reasons, non-invasive stimulation techniques, namely transcutaneous stimulation by means of Exopulse Mollii suit, might be of help in this context.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite MS diagnosis according to the 2017 McDonald criteria since at least one month.
- •Age between 18 and 75 years.
- •Ability to walk freely or with the need of support (expanded disability status scale score (EDSS) < 7.5).
- •Being free of relapses in the last three months.
- •Being French speaker, able to understand verbal instructions, and affiliated to the national health insurance (sécurité sociale).
- •Having spasticity with a score of at least 1+ on the MAS.
排除标准
- •Being included in another research protocol during the study period.
- •Inability to undergo medical monitor for the study purposes due to geographical or social reasons.
- •Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using Exopulse Mollii suit.
- •Being pregnant
- •Having a change in their pharmacological therapy in the last three months.
- •Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
- •Having a body mass index above 35 Kg/m2
- •In case of the introduction of a medical device other than Exopulse Mollii suit during the study period.
- •Patients under juridical protection (" mesure de protection judiciare : tutelle, curatelle, sauvegarde de justice ")
- •Prisoners.
结局指标
主要结局
Changes in oxyhemoglobin level at baseline and at week 2.
时间窗: This be assessed at baseline, then at week 2.
Oxygemoglobin level will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. This is a wireless device - PortaMon (Artinis Medical Systems, The Netherlands) that consists of three light emitting diodes, each sending two wavelengths and four channels to measure tissue oxygenation. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Changes in deoxyhemoglobin level at baseline and at week 2.
时间窗: This be assessed at baseline, then at week 2.
Deoxyhemoglobin level will be evaluated using the same Near Infrared Technology (NIRS) by means of a PortaMon device as previously described. The device can assess the level of deoxyhemoglobin of the muscle in question. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Changes in tissue oxygenation index at baseline and at week 2.
时间窗: This be assessed at baseline, then at week 2.
Tissue oxygenation index will be evaluated using NIRS technology. A wireless device PortaMon (Artinis Medical Systems, The Netherlands)- is designed for this purpose, it consists of three light emitting diodes, each sending two wavelengths and four channels to measure tissue oxygenation index. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
Change in total hemoglobin level at baseline and at week 2.
时间窗: This be assessed at baseline and at week 2.
Total hemoglobin level is the sum of oxyhemoglobin and deoxyhemoglobin. It will be evaluated using Near Infrared Technology (NIRS) by means of a PortaMon device. PortaMon device can assess the level of oxyhemoglobin of the muscle in question. All NIRS measurements will be done while the muscles of interest are kept at complete rest.
次要结局
- Modified Ashworth Scale (MAS)(This be assessed at baseline, then at week 2, week 4 and week 8.)
- Numerical Rating Scale of spasticity (NRS)(This be assessed at baseline, then at week 2, week 4 and week 8.)
- Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL)(This be assessed at week 4 and week 8.)
- Changes in oxyhemoglobin level at week 4 and week 8.(This be assessed at week 4 and week 8.)
- Changes in deoxyhemoglobin level at week 4 and week 8.(This be assessed at week 4 and week 8.)
- Changes in tissue oxygenation index at week 4 and week 8.(This be assessed at week 4 and week 8.)
- Changes in total hemoglobin level at week 4 and week 8.(This be assessed at week 4 and week 8.)
- Visual Analog Scale (VAS) pain(This be assessed at baseline, then at week 2, week 4 and week 8.)
- Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)(This be assessed at week 4 and week 8.)
- Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)(This be assessed at week 4 and week 8.)