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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
34
This study aims to evaluate the effects of the EXOPULSE Mollii suit, a non-invasive assistive device that delivers transcutaneous electrostimulation. The suit includes a CE-labeled class IIa control unit and class I body garments. Equipped with 58 electrodes, the full-body suit stimulates various muscle groups to reduce spasticity by activating antagonistic muscles through reciprocal inhibition, rather than causing muscle contractions. Designed to relax spastic muscles, improve range of motion, prevent atrophy, enhance circulation, and provide pain relief, the device is easy to use, requiring only one hour of daily wear, with effects lasting over 24 hours. Current treatments for spasticity, such as botulinum toxin and oral medications, have limitations like side effects and minimal mobility improvement. The EXOPULSE Mollii suit offers an innovative alternative, with early studies indicating positive impacts on mobility and motor function.
In the sham condition, the control unit will be programmed to start stimulating for 1 minute then it will shut off.
Clinical Neurophysiology Department, Henri Mondor Hospital
Créteil, VAL DE MARNE, France
Improvement in balance using the BBS (Berg Balance Scale) )
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.
Time frame: BBS will be evaluated at Day 1 (before & after the intervention, phase 1) and at Day 15 (before & after the intervention, phase 1)
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 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 fall risk across the literature.
Time frame: 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 will be evaluated by examiners using the MAS (Modified Ashworth Scale)
Time frame: 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)
Spasticity will be evaluated by patients using a VAS (Visual Analogue Scale)
Time frame: 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)
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Mobility will be assessed using the TUG (Time Up and Go)
The TUG is a validated test that assesses walking in PwMS (Bennett et al., 2017). The score is expressed as the time (in seconds) required to perform sequential motor tasks (standing up from the chair, walking to the line on the floor at a normal pace, turning, walking back to the chair at a normal pace, and finally sitting down).
Time frame: 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)
Subjective risk of fall will be assessed using the French version of the Falls Efficacy Scale-International scale (FES-I) ; a 14-item scale that assesses the perceived risk of falling.
Time frame: 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)
Subjective changes in walking would be evaluated by the Multiple Sclerosis Walking Scale - 12 (MSWS-12), a 12-item scale that examines the impact of MS on walking capacity, is a validated patient-reported measure for exploring this outcome.
Time frame: 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)
This variable will be measured using the 31-item Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL), which has good psychometric properties and yields a total score and subscores for nine dimensions: activity of daily living, psychological well-being, symptoms, friends' relationships, family relationships, satisfaction with health care, sentimental and sexual life, coping and rejection.
Time frame: 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)
VAS is a 10 mm straight horizontal line with one end meaning no pain and the other end meaning the worst pain imaginable
Time frame: 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)
VAS is a 10 mm straight horizontal line with one end meaning no fatigue and the other end meaning extreme fatigue
Time frame: 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)
It consists of 7-point scale ranging from "very much improved since the initiation of treatment" to "very much worse since the initiation of treatment" (from 1 to 7)
Time frame: 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
This blind evaluation will be done in phase 1 using a dedicated questionnaire (only for each treatment condition, since all patients will receive the same active treatment in open phase 2).
Time frame: Blinding wil be assessed at Day 1 (after the intervention) and at Day 15 (after the intervention) during Phase 1.