Multiple Sclerosis (MS) Clinical Trials

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Walking Ability of Patients With Multiple Sclerosis Using the EXOPULSE Suit: Randomized Controlled Crossover Trial

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The EXOPULSE Suit is a medical device composed of 50 electrodes capable of stimulating up to 43 major muscle groups throughout the body. The multisite electrical stimulation relaxes tense and spastic muscles, thereby enhancing mobility and balance. This non-invasive body garment is intended for home use and should be used for 1 hour every other day. This research aims to confirm the benefits of the EXOPULSE Suit in individuals with Multiple Sclerosis, including improvements in walking ability.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Centre Jacques Calvé Fondation Hopale
RECRUITING
Berck
CHU Henri Mondor
RECRUITING
Créteil
CHU Dijon
RECRUITING
Dijon
Clinique Verdaich
RECRUITING
Gaillac-toulza
Hôpital Raymond-Poincaré
RECRUITING
Garches
Hopital Saint Philibert
ACTIVE_NOT_RECRUITING
Lomme
Centre Médical Germaine REVEL
RECRUITING
Lyon
Hôpital L'Archet
NOT_YET_RECRUITING
Nice
Pole MPR Saint Hélier
RECRUITING
Rennes
Hôpital Henry Gabrielle
RECRUITING
Saint-genis-laval
Hôpital de Hautepierre
RECRUITING
Strasbourg
Contact Information
Primary
Aurelie LACROIX, Ing.
aurelie.lacroix@ottobock.com
0033 (0)7 86 29 52 03
Time Frame
Start Date: 2026-03-30
Estimated Completion Date: 2027-03
Participants
Target number of participants: 77
Treatments
Other: EXOPULSE Suit Active then EXOPUSLE Suit sham
The participant is fist using the EXOPULSE Suit in Active mode for 4 weeks, then he has a 4-weeks wash-out period, then he is using the EXOPULSE Suit in a sham mode for 4 weeks.
Other: EXOPULSE Suit in sham mode then EXOPULSE Suit in Active mode
The participant is first using the EXOPUISE Suit in sham mode for 4 weeks, then he has a 4-weeks wash-out phase, the he is using the EXOPULSE Suit in Active mode for 4 weeks.
Related Therapeutic Areas
Sponsors
Leads: Otto Bock France SNC

This content was sourced from clinicaltrials.gov