At-home full-body stimulation suit to manage spasticity and ataxia in MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.