EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis

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

CompletedNot a drug-phase studyMS (type not specified)NCT06702137

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • EXOPULSE MOLLII SUIT (active)

Placebo

  • EXOPULSE MOLLII SUIT (sham)

What it measured

Main measures

  • Improvement in balance using the BBS (Berg Balance Scale) )

    BBS will be evaluated at Day 1 (before & after the intervention, phase 1) and at Day 15 (before & after the intervention, phase 1)

    Walking and mobility

Other measures (11)

  • 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 evaluation will occur at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

    Walking and mobility

  • Assessment of the spasticity using the MAS (Modified Ashworth Scale)

    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 p

    Spasticity

  • Assessment of the spasticity using the VAS spasticity (Visual Analogue Scale)

    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

    Spasticity

  • Mobility will be assessed using the TUG (Time Up and Go)

    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 pha

    Walking and mobility

  • Mobility will be assessed using the FES-I (Falls Efficacy Scale-International scale)

    FES-I will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

    Walking and mobility

  • Mobility will be assessed using the MSWS-12 (Multiple Sclerosis Walking Scale - 12)

    MSWS-12 will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

    Walking and mobilityQuality of life (reported by participants)

  • Quality of life will be measured using the MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire)

    MusiQOL will be assessed at Day 30 (before phase 2) and at Day 60 (at the end of phase 2)

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • Pain will be assessed using a VAS (Visual Analogue Scale)

    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

    Pain

  • Fatigue will be assessed using a VAS (Visual Analogue Scale)

    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)

    Fatigue

  • Evaluation of overall improvement using the CGI (Clinical Global Impression)

    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)

Who could take part

MS (type not specified) · 18 to 75

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jun 2022

    2. Main results due

      Apr 2024

    3. Finished

      May 2024

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