Evaluating the Effects of the EXOPULSE Suit on Mobility, Walking Ability, and Balance in People With Multiple Sclerosis (EXO-MS)

Otto Bock Healthcare (Ottobock)

Status: Not yet enrolling

Conditions: Multiple Sclerosis

Treatments: Device: Electrostimulation suit

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07897760

CIV-26-06-058655 (Other Identifier)

PS00011431B-001

Details and patient eligibility

About

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.

Full description

The final sample size will be between 70 and 100, determined by the response rate and effect size, and will be defined after an IA was conducted once the first 50 participants have completed the study.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Treatment

Experimental group

Description:

The treatment group will receive regular stimulation for 60 minutes.

Treatment:

Device: Electrostimulation suit

Sham control group

Sham Comparator group

Description:

The control group will receive stimulation with the sham software enabled.

Treatment:

Device: Electrostimulation suit