Gaillac Toulza

Researchers are evaluating the EXOPULSE Suit, a medical device designed to improve walking ability in people with Multiple Sclerosis (MS) who have an Expanded Disability Status Scale (EDSS) score between 4 and 6. This device uses electrical stimulation to relax tense and spastic muscles, potentially enhancing mobility and balance. The study aims to confirm the benefits of the EXOPULSE Suit compared to a sham condition, especially for individuals who cannot use Fampridine, the only drug approved to improve walking in MS, due to contraindications or side effects. Participants will use the EXOPULSE Suit at home, worn as a non-invasive body garment with 50 electrodes that stimulate up to 43 major muscle groups. The device will be used for one hour every other day. The study involves two modes of the device: the Active mode, which stimulates muscles throughout the 60-minute session, and the Sham mode, which only stimulates during the first minute and then turns off for the remaining time. This randomized controlled crossover trial will compare walking ability between these two modes. During the study, participants' walking ability will be assessed using the Multiple Sclerosis Walking Scale 12 over 28 days. Researchers will monitor muscle spasticity, walking stability, and the participant's ability to use the device and smartphone app at home. Safety and adherence will be checked through medical visits and questionnaires. Participants will be followed throughout the study to evaluate improvements and the device's impact on daily activities and mobility.