Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis

Prior treatment

• Prior use of the EXOPULSE Suit.
• Initiation, discontinuation, or modification of any medication that could affect study outcomes within 4 weeks before screening, or any anticipated need to initiate, discontinue, or modify such medi-cation during the trial.
• Change of medical treatment regimen or initiation of new medical therapy for spasticity 4 weeks before study inclusion, this also in-cludes admission of Fampridine (4-Aminopyridine).
• Initiation of physical therapy or a change in treatment intervals and/or intensity within 4 weeks before study inclusion.
• Having received botulinum toxin injections within 3 months before study inclusion, or who are expected or scheduled to receive botulinum toxin injections during the study period.
• Planned change of medical treatment regimen or planned medical intervention during this study's duration that could bias the study results (e.g. surgery, change in pharmacotherapy, initiation or completion of physical therapy).

Other illness

• Having a cardiac pacemaker or other contraindications to using EXOPULSE Suit.
• Clinically significant cardiac, metabolic, hematologic, hepatic, im-munologic, urologic, endocrinologic, neurologic, pulmonary, psy-chiatric, dermatologic, allergic, renal, gastrointestinal, or other ma-jor diseases that in the Investigator's judgment may affect inter-pretation of study results or participant safety.
• Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum dis-ease, Lyme disease, untreated Vitamin B12 deficiency, neurosar-coidosis, cerebrovascular disorders, and untreated hypothyroid-ism.

Other

• Participants for whom no existing EXOPULSE suit size provides an adequate fit.
• Not available for study visits during planned study duration.
• Participation in any other interventional study or clinical investiga-tion within the past 4 weeks, current participation in another inter-ventional study or clinical investigation, or intention to participate in another interventional study or clinical investigation during the duration of this study.
• Being pregnant or breastfeeding.
• Having a body mass index above 35 KG/m².

• Diagnosis of MS according to the 2024 McDonald criteria (Mon-talban et al. 2025).
• Age 18 - 70 years.
• Height 100 - 205 cm.
• No relapse within the last 6 months prior to study inclusion.
• No use of high-dose steroids or apheresis procedures within the last 3 months.
• Stable immunotherapy for the last 6 months prior to study inclu-sion in accordance with AAN (for U.S. sites) and DGN (for Ger-man sites) guidelines.
• Spasticity with a score of at least 1+ on the MAS.
• EDSS score ≥ 4.0 and ≤ 6.5.
• EDSS pyramidal system score ≥ 2.
• BBS ≥15 and ≤ 48.
• Access to a smartphone capable of installing and operating the EXOPULSE App, and a stable internet connection in the stimula-tion environment. If the subject has a stable internet connection but does not own a suitable smartphone, a tablet may be provid-ed. In addition, the subject must be capable of independently us-ing the EXOPULSE App (e.g., navigating basic functions). Individ-uals who are unable to operate the App, even with instruction, should not be included.
• Ability to understand verbal instructions in German (for German sites) or English (for U.S. sites) language.
• Willingness and ability to independently provide, sign, and date the informed consent form.