EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis

Not Applicable

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT06702137
• Lead Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2022-03-01
• Status Verified: 2024-05
• Primary Completion: 2024-10-31
• Study First Submitted: 2024-11-02
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-21
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-25
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 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

Exclusion Criteria

• 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/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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Improvement in balance using the BBS (Berg Balance Scale) )	Improvement in balance will be expressed as the improvement in BBS before and after each condition (phase 1, 1 session per condition sham or active stimulation) at Visit1 (Day 0), Visit 2 (Day 15), Visit3 (Day 30) and Visit 4 (Day 45)	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.

Secondary Outcome Measures

Name	Time	Method
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	Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii 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.
Assessment of the spasticity using the MAS (Modified Ashworth Scale)	This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)	Spasticity will be evaluated by examiners using the MAS (Modified Ashworth Scale)
Assessment of the spasticity using the VAS pain (Visual Analogue Scale)	This will be assessed through study completion, an average of 3 months (at Visits 1, 2, 3, 4, 5 and 6)	Spasticity will be evaluated by patients using a VAS (Visual Analogue Scale)
Mobility will be assessed using the TUG (Time Up and Go)	Mobility will be assessed through study completion, an average of 3 months at Visits 1, 2, 3, 4, 5 and 6.	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).
Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)	Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit	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.
Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)	Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit	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.
Quality of life will be measured using the MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire)	Evaluation will occur before Visit 5 (Day 60) and after Visit 6 (Day 90) 4 weeks of using EXOPULSE Mollii suit	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.
Pain will be assessed using a VAS (Visual Analogue Scale)	This will be assessed through study completion, an average of 3 months at Visits 1, 2, 3, 4, 5 and 6.	VAS is a 10 mm straight horizontal line with one end meaning no pain and the other end meaning the worst pain imaginable
Fatigue will be assessed using a VAS (Visual Analogue Scale)	This will be assessed through study completion, an average of 3 months at Visits 1, 2, 3, 4, 5 and 6.	VAS is a 10 mm straight horizontal line with one end meaning no fatigue and the other end meaning extreme fatigue
Evaluation of overall improvement using the CGI (Clinical Global Impression)	This will be assessed at Visit2 (Day 15) , Visit4 (Day 45) and Visit6 (Day 90) since CGI is designed to be applied after interventions	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)
Evaluation of patient's blinding to the type of stimulation in the crossover trial	This will only be assessed at Visit2 (Day 15) and Visit4 (Day 45) of Phase 1.	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).

Trial Locations

Locations (1)

Clinical Neurophysiology Department, Henri Mondor Hospital; 🇫🇷 Creteil, VAL DE Marne, France