Clinical trial NCT06702137: EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis
Official title: The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Spasticity
Motor Functions
Quality of life
Lead sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It is a randomized, controlled, double-blind, and cross-over study. Phase 1 is a randomized, controlled, double-blind, and cross-over study. In this phase, each participant will be randomly assigned to receive one session of active stimulation and one session of sham stimulation using the EXOPULSE Mollii suit (phase 1).

The crossover design is appropriate for assessing symptomatic treatment of this chronic and relatively stable disease. Furthermore, the sessions will be separated by a wash-out interval of two weeks. Thus, a 2-week washout period should be enough to prevent a potential carry-over effect.

At the end of phase 1 (two weeks after the second session of active or sham), an open-label phase (phase 2) will be proposed for all patients and will consist of 4 weeks of active stimulation (every other day stimulations for a total of 14 sessions).

In total, each participant will be included in the study for 8 weeks (4 weeks for phase 1 and 4 weeks for phase 2).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in balance using the BBS (Berg Balance Scale) )
timeFrame: BBS will be evaluated at Day 1 (before & after the intervention, phase 1) and at Day 15 (before & after the intervention, phase 1)
Secondary outcomes:
measure: 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
timeFrame: BBS evaluation will occur at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
measure: Assessment of the spasticity using the MAS (Modified Ashworth Scale)
timeFrame: 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)
measure: Assessment of the spasticity using the VAS spasticity (Visual Analogue Scale)
timeFrame: 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)
measure: Mobility will be assessed using the TUG (Time Up and Go)
timeFrame: 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)
measure: Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)
timeFrame: FES-I will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
measure: Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)
timeFrame: MSWS-12 will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
measure: Quality of life will be measured using the MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire)
timeFrame: MusiQOL will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)
measure: Pain will be assessed using a VAS (Visual Analogue Scale)
timeFrame: 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)
measure: Fatigue will be assessed using a VAS (Visual Analogue Scale)
timeFrame: 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)
measure: Evaluation of overall improvement using the CGI (Clinical Global Impression)
timeFrame: 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)
measure: Evaluation of patient's blinding to the type of stimulation in the crossover trial
timeFrame: Blinding wil be assessed at Day 1 (after the intervention) and at Day 15 (after the intervention) during Phase 1.
Other outcomes:
Locations:
city: Creteil
country: France
facility: Clinical Neurophysiology Department, Henri Mondor Hospital
state: Val de Marne
Study officials:
affiliation: Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
name: Samar S AYACHE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: