Using the EXOPULSE Mollii Suit to Improve Motor Function in Multiple Sclerosis

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

This study is testing whether wearing the EXOPULSE Mollii suit can help improve movement and reduce symptoms for people with multiple sclerosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institut De La Colonne Vertebrale Et Des Neurosciences (Academic / other)
• Locations: 1 site (Creteil, VAL DE Marne)
• Trial ID: NCT06702137 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of the EXOPULSE Mollii suit, a non-invasive stimulation device, on motor functions and symptoms related to multiple sclerosis (MS). It employs a randomized crossover, sham-controlled, double-blind design to compare the outcomes of active versus sham treatment sessions. Participants will undergo a single session of treatment followed by a two-week washout period, after which they will enter an open-label phase to assess the effects of the suit over a four-week period with sessions every other day. The study aims to provide insights into the potential benefits of this innovative approach for managing spasticity in MS patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of multiple sclerosis and experiencing spasticity.

Not a fit: Patients who are pregnant, have certain medical devices, or have recently changed their pharmacological therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved motor function and quality of life for patients with multiple sclerosis experiencing spasticity.

How similar studies have performed: While the use of non-invasive stimulation techniques is gaining interest, this specific approach with the EXOPULSE Mollii suit is relatively novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Creteil, VAL DE Marne

• Clinical Neurophysiology Department, Henri Mondor Hospital — Creteil, VAL DE Marne, France (Recruiting)

Study contacts

• Principal investigator: Samar S AYACHE, MD, PhD — Clinical Neurophysiology department, Henri Mondor Hospital, Creteil, France
• Study coordinator: Samar S AYACHE, MD, PhD

Conditions Multiple Sclerosis; Spasticity; Motor Functions; Quality of life