Status:
NOT_YET_RECRUITING
At Home Use of Stimulation Suits for Managing MS Symptoms
Lead Sponsor:
Daphne Kos
Collaborating Sponsors:
Danish MS Hospitals, Haslev and Ry
Universitair Ziekenhuis Brussel
Conditions:
Multiple Sclerosis
MS (Multiple Sclerosis)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 spastici...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07202195
Start Date
September 1 2025
End Date
September 1 2027
Last Update
October 1 2025
Active Locations (2)
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1
Nationaal MS Center Melsbroek
Steenokkerzeel, Belgium, 1820
2
The Danish MS Hospitals
Ry, Denmark, 8680