At Home Use of Stimulation Suits for Managing MS Symptoms
Recruiting · NCT07202195 · Interventional (participants receive a specific treatment) · Lead sponsor: Daphne Kos
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study is being carried out at Multiple Sclerosis (MS) centers to evaluate whether a full-body stimulation suit at home can help people with Multiple Sclerosis (pwMS) reduce symptoms like spasticity (muscle stiffness) and ataxia (poor coordination), and improve daily functioning. Can pwMS who experience spasticity or ataxia benefit from using a stimulation suit for 6 weeks? Researchers will compare two groups: an intervention group (who will use the suit) and a control group (who will not use the suit). Participants in the intervention group will: * Wear the suit for 6 weeks in total every day or every other day (1 week during their MS center admission and 5 weeks at home). * Receive their usual care in addition to wearing the suit. * Undergo clinical tests at the MS center after 1 week and 6 weeks of stimulation. Participants in the control group will: * Receive their usual care. * Undergo clincial tests at the same time points as the other group.
Who can take part
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 is running
2 locations listed.
- The Danish MS Hospitals - Ry, Denmark
- Nationaal MS Center Melsbroek - Steenokkerzeel, Belgium