Not yet recruitingNot applicable

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

EXO-MS: Effect of the EXOPULSE Suit on Mobility, Walking, and Balance in Multiple Sclerosis: A Double-Blind, Controlled, Parallel-Group Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the EXOPULSE Suit, which uses electrical pulses, can improve walking, balance, and movement in adults with multiple sclerosis (MS) and stiff muscles. It also checks safety and effects on pain, hand skills, tiredness, and quality of life. Participants use the suit at home for one hour every other day for 4 weeks; some may receive sham (placebo) stimulation.

This clinical research study is investigating whether the EXOPULSE Suit, a wearable device that delivers electrical stimulation, can help improve movement difficulties caused by spasticity in adults with multiple sclerosis (MS). The main goal of the study is to evaluate the effect of the EXOPULSE Suit on functional mobility, with particular focus on walking ability and balance. The study will also assess the safety of the device by monitoring any adverse events that occur during the study. Researchers will additionally evaluate the effects of the EXOPULSE Suit on: * Pain * Hand and finger dexterity * Fatigue * Quality of life Participants will be randomly assigned to receive one of the stimulation programs being evaluated in the study. Some participants may receive a sham (placebo) stimulation. Neither the participants nor the study staff performing the assessments will know which stimulation program a participant has been assigned to during the study. This approach, known as blinding, helps ensure that the study results are as objective and reliable as possible. Participants will use the EXOPULSE Suit for one hour every other day during a 4-week home-use period. Clinical assessments will be performed before and after the treatment period to evaluate changes in mobility and other symptoms. It is important to note that individuals may experience the stimulation differently. Some participants may clearly feel the stimulation, while others may feel it only slightly or not at all. Not feeling the stimulation does not necessarily indicate which study group a participant has been assigned to, and a treatment effect may still be possible even when the stimulation is not perceived. To ensure meaningful study results, participants are encouraged to use the EXOPULSE Suit as instructed throughout the study period, even if they do not notice a sensation of stimulation or an immediate improvement in their symptoms. The study uses an adaptive design, meaning that an interim analysis will be performed during the study to determine the number of participants needed to reliably evaluate the study objectives.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have MS diagnosed using the 2024 McDonald rules, and be 18–70 years old.
  • Be 100–205 cm tall.
  • Have had no MS flare-up in the past 6 months and no high-dose steroids or apheresis (a blood-filtering treatment) in the past 3 months.
  • Have had stable immune-system treatment for the past 6 months that follows the required treatment guidelines.
  • Have muscle stiffness with a MAS score of at least 1+. Have an EDSS disability score of 4.0–6.5 and an EDSS muscle-control score of at least 2.
  • Have a Berg Balance Scale (BBS) score of 15–48, which measures balance.
  • Have stable internet where you use the suit and a phone that runs the EXOPULSE App. A tablet may be provided if needed. You must be able to use the app on your own.
  • Understand spoken English at U.S. sites or German at German sites, and be willing and able to sign and date the consent form yourself.

Who can't join

  • Have a heart pacemaker or another reason the suit is unsafe for you, have used the suit before, or cannot fit any available suit size.
  • Cannot attend study visits, or have taken part in another treatment study in the past 4 weeks, are taking part now, or plan to during this study.
  • Started, stopped, or changed medicines that could affect results within 4 weeks before screening, or expect such changes during the study. Changes to stiffness treatment, including fampridine, within 4 weeks before joining also rule you out.
  • Started physical therapy or changed how often or how intensely you receive it within 4 weeks before joining, or plan treatment changes or procedures that could affect results during the study.
  • Had botulinum toxin injections within 3 months before joining, or expect to receive them during the study.
  • Are pregnant or breastfeeding, or have a body mass index (BMI), a measure based on height and weight, above 35.
  • Have another major health condition that the study doctor believes could affect your safety or the study results.
  • Have another condition that can look like MS, such as Lyme disease, untreated vitamin B12 deficiency, or an untreated underactive thyroid.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Having a cardiac pacemaker or other contraindications to using EXOPULSE Suit. * Participants for whom no existing EXOPULSE suit size provides an adequate fit. * Not available for study visits during planned study duration. * Prior use of the EXOPULSE Suit. * 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. * 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). * Being pregnant or breastfeeding. * 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. * Having a body mass index above 35 KG/m².

Study sites (1)

IL