EXOPULSE Suit to improve walking in people with multiple sclerosis
Walking Ability of Patients With Multiple Sclerosis Using the EXOPULSE Suit: Randomized Controlled Crossover Trial
NA · Otto Bock France SNC · NCT07252895
This will try the EXOPULSE Suit, a wearable that delivers multisite electrical stimulation, to see if it helps people with multiple sclerosis walk better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 77 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Otto Bock France SNC (industry) |
| Locations | 11 sites (Berck and 10 other locations) |
| Trial ID | NCT07252895 on ClinicalTrials.gov |
What this trial studies
The EXOPULSE Suit is a non-invasive wearable garment with 50 electrodes that can stimulate up to 43 major muscle groups to reduce spasticity and support balance. In this interventional study, people with MS and moderate disability (EDSS 4–6) will use the suit at home for one hour every other day and outcomes will focus on walking ability. Participants will use the suit in active or sham modes so the effects of the electrical stimulation can be compared. The trial is being run at three French centers and targets people who cannot or prefer not to use fampridine.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed MS diagnosis, EDSS between 4 and 6, measurable lower-limb spasticity, stable walking for at least two weeks, who have not previously used the EXOPULSE Suit and who cannot take or do not tolerate fampridine.
Not a fit: People with implanted electronic devices (e.g., pacemakers), contraindications to the suit, severe disability outside the EDSS 4–6 range, no measurable lower-limb spasticity, or under 18 years old are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the suit could offer a non-drug option to reduce spasticity and improve walking speed, balance, and daily mobility for people with MS.
How similar studies have performed: Multisite electrical stimulation and other wearable neuromodulation approaches have shown preliminary mobility benefits in MS, but the EXOPULSE Suit itself is relatively new and needs confirmatory trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Person with a clear Multiple Sclerosis diagnosis according to the 2017 revision of the McDonald criteria since at least 3 months. * Person with an Expanded Disability Status Scale (EDSS) score ≥ 4 and ≤ 6 * Person with stable walking ability for at least two weeks prior to the inclusion visit (variation at the MSWS-12 questionnaire \< 8/100 points) * Person not treated with fampridine due to contra-indication or adverse events or not respondent or no longer respondent or reluctant to taking drugs * Person with spasticity at the lower limb(s), attested by a Modified Ashworth Scale ≥ 1+ of at least one of the following muscle groups: quadriceps, hamstrings, triceps surae, tibialis anterior * Person who never tried EXOPULSE SUIT Exclusion Criteria: * Person under 18 years old * Person having a contraindication to using EXOPULSE SUIT * Person using an electronic life-support equipment, e.g. pacemakers or hight-frequency surgical equipment and person using an ECG equipment * Person affected by other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain). * Person with relapses over the last 3 months before the inclusion * Person who had a modification of his/her medical treatments of the multiple sclerosis or related to motor performance over the last 3 months before the inclusion * Person who had a new medical treatment of the multiple sclerosis or related to motor performance over the last 3 months before the inclusion * Person who had an injection of botulinum toxin in at least one of the main muscle groups of the lower limbs over the last 4 months before the inclusion * Person planning to use a new medical device during the study (ex: ankle-foot orthosis…) * Person undergoing or planning to undergo an intensive rehabilitation phase * Person that is part of another study * Person who cannot be fitted with EXOPULSE SUIT due to inexistent Suitable size of the Suit (eg: BMI\>35; user height \< 100 cm or \> 205cm) * Person who does not have a smartphone or who cannot or does not want to use his/her smartphone for operating the EXOPULSE App * Person not available to undergo all medical visits during the study * Person unable to understand verbal and written instructions in french * Pregnant person * Persons under juridical protection * Prisoners
Where this trial is running
Berck and 10 other locations
- Centre Jacques Calvé Fondation Hopale — Berck, France (RECRUITING)
- CHU Henri Mondor — Créteil, France (RECRUITING)
- CHU Dijon — Dijon, France (RECRUITING)
- Clinique Verdaich — Gaillac-Toulza, France (RECRUITING)
- Hôpital Raymond-Poincaré — Garches, France (RECRUITING)
- Hopital Saint Philibert — Lomme, France (ACTIVE_NOT_RECRUITING)
- Centre Médical Germaine REVEL — Lyon, France (RECRUITING)
- Hôpital L'Archet — Nice, France (NOT_YET_RECRUITING)
- Pole MPR Saint Hélier — Rennes, France (RECRUITING)
- Hôpital Henry Gabrielle — Saint-Genis-Laval, France (RECRUITING)
- Hôpital de Hautepierre — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Aurelie LACROIX, Ing.
- Email: aurelie.lacroix@ottobock.com
- Phone: 0033 (0)7 86 29 52 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, neuromodulation, suit, walking ability, multi-site electrical stimulation