The Effects of EXOPULSE Mollii Suit on Spasticity and Muscular Oxygenation in Patients With Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
研究概览
简要总结
The goal of this clinical trial is to demonstrate the improvement of muscular oxygenation in patients with Multiple Sclerosis and spasticity using Exopulse Molli suit stimulation. The main questions it aims to answer are:
- to evaluate the short-term impact of EXOPULSE Molli suit on muscular oxygenation in adult MS patients suffering from spasticity.
- to assess the effects of Exopulse Mollii suit on spasticity, pain, fatigue, quality of life (QoL), walking and risk of fall.
Study subjects will participate in:
- One baseline visit for inclusion in the study during which the patient will undergo the first session (active or sham) along with an evaluation before and after the session
- One visit after two weeks during which the patient will undergo the second session (active or sham) along with an evaluation before and after the session
- One visit two weeks after the second stimulation; where the patients will undergo a fifth evaluation and receive the EXOPULSE Molli Suit for the four-week open label phase to use the suit at home for an active stimulation session every other day for four weeks.
- One visit at the end of the open label phase to perform the sixth and last evaluation and return the EXOPULSE Molli suit.
Researchers will compare both Active and Sham groups to demonstrate the improvement of muscular oxygenation in patients with MS and spasticity using Exopulse Molli.
详细描述
The study is a randomized crossover, sham-controlled, double-blind trial to demonstrate the improvement of tissue oxygenation and frequent MS symptoms following a single session of "active" versus "sham" Exopulse Mollii suit separated by 2 weeks. A 2-week washout period should be enough to prevent a potential carry over effect. After this phase (phase 1), a second open label phase (phase 2) will be proposed for patients to understand the effects of Exopulse Mollii suit employed for one month (3 sessions per week) on tissue oxygenation and 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
- Supportive Care
- 盲法
- None
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.
- •Having spasticity with a score of at least 1+ on the MAS.
- •Female patients of child-bearing potential must agree to use adequate birth control measures
- •Voluntarily given, fully informed written and signed consent obtained before any study related procedures are conducted
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/m
- •In case of the introduction of a medical device other than Exopulse Mollii suit during the study period.
- •Patients under juridical protection.
- •Prisoners.
结局指标
主要结局
Muscular Oxygenation using Near-infrared spectroscopy (NIRS) Measurements
时间窗: To be assessed at baseline, week 2, week 4 and week 8
Muscular Oxygenation will be assessed using the Near-infrared spectroscopy (NIRS) technology using a PortaMon device it will be employed to assess tissue oxygenation parameter (hemoglobin (tHb) in the territory of the spastic muscles before and after each session.
次要结局
- Visual Analog Score for fatigue.(This to be assessed at baseline, then at week 2, week 4 and week 8.)
- Walking ability.(Two weeks after the second stimulation and at the end of phase 2.)
- Height(Baseline.)
- Numerical Rating Scale for spasticity.(This to be assessed at baseline, then at week 2, week 4 and week 8.)
- Multiple Sclerosis International Quality of Life Questionnaire.(Two weeks after the second stimulation and 4 weeks later at the end of phase 2.)
- Visual Analog Score for pain.(This to be assessed at baseline, then at week 2, week 4 and week 8.)
- Fall risk.(Two weeks after the second stimulation and at the end of phase 2.)
- Overall Clinical Improvement.(This to be assessed at baseline, then at week 2, and week 8.)
- Blinding Questionnaire.(This to be assessed at baseline, then at week 2.)
- Weight(Baseline.)
- Muscle tone.(Baseline, and through study completion.)
- Body Mass Index (BMI)(Baseline.)
研究者
Naji Joseph Riachi
Principal Investigator
Sheikh Shakhbout Medical City