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

Condition(s) studied

Investigational drug(s) / intervention(s)

Electrostimulation suit: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Balance responder rate: Percentage of patients achieving a clinically meaningful improvement in balance, as measured by the Berg Balance Scale (BBS), in the treatment group compared with sham-control group. — From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
  Percentage of patients achieving a clinically meaningful improvement in balance, defined as a ≥6-point improvement from baseline 1 on the Berg Balance Scale (BBS) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The Berg Balance Scale (BBS) is a 14-item clinical assessment designed to evaluate static and dynamic balance during functional tasks. Each item is scored on a 5-point ordinal scale ranging from 0 to 4, with a total score range of 0 to 56. Higher scores indicate better balance performance and lower fall risk, while lower scores indicate greater balance impairment. Points are deducted when a task cannot be completed independently, requires supervision or assistance, or does not meet the specified performance criteria. The BBS assesses balance during activities such as sitting, standing, transferring, reaching, turning, and single-leg stance.
• Walking responder rate: Percentage of patients achieving a clinically meaningful improvement in walking ability, on the transformed 0-100 Multiple Sclerosis Walking Scale-12 (MSWS-12), in the treatment group compared with the sham -control group. — From Baseline 1 (start of treatment) to the post-treatment assessment after 28 days of treatment (-3/+10 days).
  Percentage of patients achieving a clinically meaningful improvement in walking ability, defined as a ≥8-point decrease from baseline 1 on the transformed 0-100 Multi-ple Sclerosis Walking Scale-12 (MSWS-12) after 28 days (-3/+10 days) of treatment, compared with the corresponding proportion in the sham-control group. The MSWS-12 is a self-report questionnaire designed to assess the impact of MS on an individual's walking ability. It consists of 12 items, each rated on a scale from 1 to 5, where 1 indicates no limitation, and 5 indicates extreme limitation. The items cover various aspects of walking, e.g.: ability to walk and run, climbing stairs, standing balance, walking distance and speed, effort required for walking. The total score is calculated by summing up the responses, which can then be transformed to a scale from 0 to 100, with higher scores indicating a greater impact on walking ability.

Trial sites (2)

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