Otto Bock Healthcare Products GmbH
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.
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.
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 sma…
One hour stimulation with an electrostimulation suit every other day. The EXOPULSE Suit provides low-intensity sensory electrical stimulation below the motor threshold. Unlike neuromuscular electrical stimulation (NMES), it is not intended to induce muscle contractions. The stimulation is conceptually similar to TENS but is delivered at lower intensities.