At-home full-body stimulation suit to manage spasticity and ataxia in MS
Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT
This project will try whether wearing a full-body electrical stimulation suit for six weeks helps people with MS who have spasticity or ataxia reduce symptoms and improve daily functioning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 2 sites (Steenokkerzeel and 1 other locations) |
| Trial ID | NCT07202195 on ClinicalTrials.gov |
What this trial studies
The study compares two groups of people with MS: an intervention group who will wear a full-body electrostimulation suit and a control group who will receive usual care. Intervention participants wear the suit during a one-week admission at the MS center and then at home for five additional weeks, using it daily or every other day. Clinical tests are performed at the MS center after 1 week and after 6 weeks to measure spasticity, ataxia, and functional changes. Usual care continues for both groups throughout the study.
Who should consider this trial
Good fit: Adults with a confirmed diagnosis of multiple sclerosis who have spasticity (MAS ≥ 1) or ataxia (SARA ≥ 4) and who can understand instructions and complete questionnaires are the intended participants.
Not a fit: People with implanted electronic devices, recent relapse or recent changes in disease-modifying treatment, recent Botulinum toxin A, acute musculoskeletal problems, or insufficient cognitive ability are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the suit could reduce muscle stiffness and improve coordination and everyday mobility for people with MS.
How similar studies have performed: Small studies of targeted electrical neuromodulation have shown mixed benefits for MS symptoms, but full-body stimulation suits are a relatively novel approach with limited published evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible participants must have ataxia or spasticity alongside impairments in upper or lower extremity physical function. MAS score ≥ 1 will be used as an inclusion criterion to determine the presence of spasticity. SARA score ≥ 4 will be used as an inclusion criterion to determine the presence of ataxia. Note: one of the two criteria (MAS score or SARA score) must be fulfilled for a pwMS to be eligible. * The patient must have the cognitive abilities to understand instructions and to be able to complete the questionnaires adequately * Diagnosis of multiple sclerosis. Exclusion Criteria: * Implanted devices (like pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, high frequency operation equipment ) * Change in disease modifying treatment within the last 3 months * Use of Botuline Toxine A within the last 3months * Recent relapse within the last 3 months * Acute musculoskeletal problems that hinder the test performance, * Pregnancy * Sizes bigger than 3XL (triple eXtra Large) * Skin eruptions and/or skin areas in the stimulation zone that are swollen, infected or inflamed.
Where this trial is running
Steenokkerzeel and 1 other locations
- Nationaal MS Center Melsbroek — Steenokkerzeel, Belgium (Recruiting)
- The Danish MS Hospitals — Ry, Denmark (Recruiting)
Study contacts
- Principal investigator: Daphne Kos — Universitair Ziekenhuis Brussel
- Study coordinator: Daphne Kos
- Email: daphne.kos@uzbrussel.be
- Phone: +32496107849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.