EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis (EXOSEP 2)

Study Overview
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Brief Summary
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The goal of this clinical trial is to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit stimulation in Multiple Sclerosis patients with spasticity. The main questions it aims to answer are: to evaluate the short-term impact of EXOPULSE Mollii suit on balance in adult MS patients suffering from spasticity. to assess the effects of EXOPULSE Mollii suit on mobility, upper and lower limbs muscle tone, pain, fatigue and quality of life. Participants will participate in: One baseline visit for inclusion during which the patient will undergo the first session (active or sham) along with evaluations (before and after the session) One visit after two weeks during which the patient will undergo the second session (active or sham) along with evaluations (before and after the session) One visit after two weeks of the second stimulation condition; the patients will undergo a third evaluation and receive the EXOPULSE Mollii Suit for the four-week open label phase and will 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 fourth and last evaluation and return the EXOPULSE Mollii suit. Researchers will compare both Active and Sham groups to demonstrate the improvement of motor functions related symptoms in patients with MS and spasticity using Exopulse Mollii suit.

Detailed Description
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The study is 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 stimulation. in phase 1, the patient will receive two stimulations separated by a two-week washout period. The patients will be randomized to receive either active/sham or sham/active and both patients and investigators will be blinded to the order in which the stimulation will be given. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of phase 1, a second open label phase (phase 2) of this trial will be proposed to all patients where they will receive active stimulation every other day at home over four weeks (for a total of 14 sessions). This will help understand the long term effects of EXOPULSE Mollii suit stimulation on MS related symptoms.

Official Title
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The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP 2)

Conditions
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Sclerosis, Multiple, MS (Multiple Sclerosis), Spasticity, Muscle, Spastic

Intervention / Treatment
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* Device: EXOPULSE Mollii Suit Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 able to understand verbal instructions. 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. Exclusion Criteria: 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^2. In case of the introduction of a medical device other than EXOPULSE Mollii suit during the study period. Patients under juridical protection. Prisoners.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EXOPULSE Mollii Suit Stimulation Active<br>This will be the EXOPULSE Mollii Suit Active Stimulation. Stimulation will go on for 60 minutes while control unit is on for 60 minutes. | Device: EXOPULSE Mollii Suit Stimulation<br>* We 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 stimulation. in phase 1, the patient will receive two stimulations separated by a two-week washout period. The patients will be randomized to receive either active/sham or sham/active and both patients and investigators will be blinded to the order in which the stimulation will be given. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of phase 1, a second open label phase (phase 2) of this trial will be proposed to all patients where they will receive active stimulation every other day at home over four weeks (for a total of 14 sessions). This will help understand the long term effects of EXOPULSE Mollii suit stimulation on MS related symptoms.<br>|
| Sham Comparator: EXOPULSE Mollii Suit Stimulation Sham<br>This will be the EXOPULSE Mollii Suit Sham Stimulation. Stimulation will go on for 1 minute then it turns off while the control unit will remain on for total of 60 minutes. | Device: EXOPULSE Mollii Suit Stimulation<br>* We 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 stimulation. in phase 1, the patient will receive two stimulations separated by a two-week washout period. The patients will be randomized to receive either active/sham or sham/active and both patients and investigators will be blinded to the order in which the stimulation will be given. A 2-week washout period should be enough to prevent a potential carry over effect. Two weeks after the end of phase 1, a second open label phase (phase 2) of this trial will be proposed to all patients where they will receive active stimulation every other day at home over four weeks (for a total of 14 sessions). This will help understand the long term effects of EXOPULSE Mollii suit stimulation on MS related symptoms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance using Berg Balance Scale (BBS) | Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (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 risk of fall across the literature. | To be assessed at baseline. | 
| Balance using Berg Balance Scale (BBS) | Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (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 risk of fall across the literature. | To be assessed at week 2. | 
| Balance using Berg Balance Scale (BBS) | Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (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 risk of fall across the literature. | To be assessed at week 4. | 
| Balance using Berg Balance Scale (BBS) | Balance will be assessed using the 14-item Berg Balance Scale (BBS) which has good psychometric properties in Patients with Multiple Sclerosis (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 risk of fall across the literature. | To be assessed at week 8. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score for spasticity. | Spasticity will be measured using a visual analog score from 0 to 10, 0 being no spasticity and 10 being the worst possible spasticity. | This to be assessed at baseline, then at week 2, week 4 and week 8. | 
| Mobility. | Mobility will be evaluated by the 12-item Multiple Sclerosis Walking Scale (MSWS-12). Each one of the 12 items will be assessed and assigned numbers from 1 to 5, 1 being not at all to 5 being extremely common, and the results will be added to a total of 60, so the higher the score, the better the mobility. | Two weeks after the second stimulation and 4 weeks later at the end of phase 2. | 
| Visual Analog Score for pain. | Pain will be measured using a visual analog score from 0 to 10, 0 being no pain, to 10 being the worst possible pain. | This to be assessed at baseline, then at week 2, week 4 and week 8. | 
| Multiple Sclerosis International Quality of Life Questionnaire. | Quality of life will be measured using the 31-item Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL). This questionnaire consists of 31 questions covering 9 domains including: 1- activity of daily living; 2- physical well-being; 3- relationships with friends; 4- symptoms; 5- relationships with family; 6- relationships with health care systems; 7- sentimental and sexual life; 8- coping; and 9- rejection. The questions are answered by ticking or checking the box that describes best of what patients would feel ranging from 0 to 4, 0 being not at all and 4 always or very much. For MusiQoL, the score of each of the nine sub domains is calculated as the average for the set of questions making up the domain. An overall score is then calculated as the average of all the scores for each subdomain. Prior to computing the final overall score, each domain-specific score is linearly transformed to a 0-100 scale with 0 being the worst quality of life and 100 the best. | Two weeks after the second stimulation and 4 weeks later at the end of phase 2. | 
| Overall Clinical improvement. | Evaluation of overall Clinical improvement will be done using the 7-point Clinical Global Impression (CGI). Patient will fill a questionnaire that will address their clinical situation as follows: Very much improved. Much improved. Slightly improved. No change. Slightly worse. Much worse. Very much worse. The score will range from 1-7, 1 being the best clinical outcome and 7 the worst. | This to be assessed at baseline, then at week 2, and week 8. | 
| Blinding Questionnaire. | Evaluation of patient's blinding to the type of stimulation in the crossover trial periods using a dedicated questionnaire. Patients will be asked whether they think they received the sham or active stimulation. No scale will be used for this measure. | This to be assessed at baseline, then at week 2. | 
| Visual Analog Score for fatigue. | Fatigue will be measured using a visual analog score from 0 to 10, 0 being no fatigue, to 10 being the worst possible fatigue. | This to be assessed at baseline, then at week 2, week 4 and week 8. | 
| Muscle tone. | Muscle tone will be evaluated by the Modified Ashworth Scale (MAS). Scores will range from 0 to 4, 0 being no increase or normal muscle tone, to 4 being rigidity in flexion or extension of muscles. | This to be assessed at baseline, then at week 2, week 4 and week 8. | 
| Fall Risk | Fall risk will be assessed using the Falls Efficacy Scale-International scale. It is a 16-item scale, including a range of functional activities, that assesses the perceived risk of falling, using a score that will range from 1 to 4, 1 being not at all concerned to 4 being very concerned. Items are summed to a total score that will range from a minimum of 16 (no concern about falling) to a maximum of 64 (severe concern about falling). | Two weeks after the second stimulation and 4 weeks later at the end of phase 2. | 
| Weight. | The patient weight will be measured and recorded in kilograms. | Baseline | 
| Height. | The patient height will be measured and recorded in centimeters. | Baseline | 
| Time Up and Go (TUG) | Patients have to stand up from a chair when they hear the verbal instruction go, walk a distance of 3 meters, turn around, walk back to the chair and sit down. Timing starts with the verbal instruction go' and stops when the patients return to the seated position. The score consists of the time taken to complete the test activity, measured in seconds. | Baseline, and through study completion | 
| Body Mass Index (BMI) | The weight and height will be combined to report BMI in kg/m^2. BMI of 35 kg/m^2 or more will be used as an exclusion criterion for the study. | Baseline |