The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Improvement in balance using the BBS (Berg Balance Scale) )
研究概览
简要总结
Spasticity is a frequent and debilitating symptom in patients with multiple sclerosis (MS). It can alter the patients' balance, mobility, as well as their quality of life. 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.
详细描述
The investigators designed a randomized crossover, sham-controlled, double blind trial to demonstrate the improvement of motor functions and MS related symptoms following a single session of "active" versus "sham" EXOPULSE Mollii suit. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of this phase (phase 1), a second phase of this trial, an open label phase, will be proposed for all patients to understand the effects of EXOPULSE Mollii suit employed over four weeks (a session every other day for a total of 14 sessions) on MS related symptoms.
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
- Triple (Participant, Care Provider, 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).
- •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.
- •Having a BBS score ≤46 associated in the literature with a risk of fall
排除标准
- •Being included in another research protocol during the study period.
- •Inability to undergo medical monitoring 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/m
- •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
Improvement in balance using the BBS (Berg Balance Scale) )
时间窗: BBS will be evaluated at Day 1 (before & after the intervention, phase 1) and at Day 15 (before & after the intervention, phase 1)
Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in PwMS (concurrent validity, interrater reliability). The scale rates the balance using 56 points, with higher scores indicating better balance abilities. A score equal to or below 45 is commonly associated with the risk of falls across the literature.
次要结局
- Assessment of the cumulative effects of EXOPULSE Mollii suit on balance using the BBS (Berg Balance Scale) after 4 weeks of using Exopulse Molii Suit(BBS evaluation will occur at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Assessment of the spasticity using the MAS (Modified Ashworth Scale)(Spasticity according to MAS will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Assessment of the spasticity using the VAS spasticity (Visual Analogue Scale)(VAS spasicity will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Mobility will be assessed using the TUG (Time Up and Go)(Mobility according to TUG will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)(FES-I will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)(MSWS-12 will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Quality of life will be measured using the MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire)(MusiQOL will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Pain will be assessed using a VAS (Visual Analogue Scale)(Pain according to VAS will be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Fatigue will be assessed using a VAS (Visual Analogue Scale)(Fatigue according to VAS be assessed through study completion at Day 1 (before and after the intervention, phase 1), at Day 15 (before and after the intervention, phase 1), at Day 30 (before phase 2) and at Day 60 (at the end of phase 2))
- Evaluation of overall improvement using the CGI (Clinical Global Impression)(CGI will be assessed at Day 1 (after the intervention, phase 1), at Day 15 (after the intervention, phase 1) and at Day 60 (at the end of phase 2))
- Evaluation of patient's blinding to the type of stimulation in the crossover trial(Blinding wil be assessed at Day 1 (after the intervention) and at Day 15 (after the intervention) during Phase 1.)