NCT06702137Completed
EXOPULSE Mollii Suit, Motor Function & Multiple Sclerosis
The Effects of EXOPULSE Mollii Suit on Motor Functions in Patients With Multiple Sclerosis (EXOSEP Study)
Source: ClinicalTrials.gov · Last updated 18 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 34 (actual)
- First submitted
- 2 Nov 2024
- Start date
- 1 Jun 2022
- Primary completion date
- 2 Apr 2024
- Lead sponsor
- Institut De La Colonne Vertebrale Et Des Neurosciences
- Diseases
- Multiple sclerosis
- NCT number
- NCT06702137
What you commit to
- Study type: Interventional
- Participants enrolled: 34
- From 1 Jun 2022 to the primary completion date, 2 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having a change in their pharmacological therapy in the last three months.
Other illness
- Having a cardiac stimulator, a ventriculoperitoneal shunt, an intrathecal baclofen pump or other contraindications to using EXOPULSE Mollii suit.
- Suffering from other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
Other
- 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.
- Being pregnant.
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Neurophysiology Department, Henri Mondor Hospital Coordinator of this site? Confirm its status | Créteil | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.