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RecruitingNot ApplicableNCT07202195

At Home Use of Stimulation Suits for Managing MS Symptoms

Home-Based Neuromodulation Suits for Reducing Spasticity and Ataxia in Multiple Sclerosis: A Multi-center RCT

Sponsor

Daphne Kos

Enrollment

70 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Multiple SclerosisSpasticityAtaxia - OtherMS (Multiple Sclerosis)Spasticity With Multiple SclerosisAtaxia, CerebellarAtaxia, MotorHome Based Care

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a wearable electrical stimulation suit can help people with multiple sclerosis (MS) manage symptoms like muscle stiffness (spasticity) or unsteady movement (ataxia) in their own homes. The suit sends gentle electrical signals to muscles to improve function and reduce symptoms. **You may be eligible if...** - You have been diagnosed with multiple sclerosis - You have spasticity (muscle stiffness) or ataxia (problems with balance and coordination) affecting your arms or legs - You have enough cognitive ability to understand instructions and complete questionnaires **You may NOT be eligible if...** - You have implanted devices such as a pacemaker, baclofen pump, neurostimulator, or defibrillator - Your medication has recently changed in a way that could affect the results - You have other conditions that would make electrical stimulation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEelectro-stimulation suit

In EXOPULSE Mollii Suit is a multi-channel full-body suit with a low energy electrical stimulation - 20 Volt and 20 Hz. It generates 2 milliamp pulses (into 0-10,000 Ohms) with the following parameters: * Pulse width: variable between 25 and 170 μs. * Length of period: 50 ms. * Maximum amplitude: 20 V. It is composed of a control unit, a jacket and pants, with 58 embed-ded electrodes, in direct contact with the skin, and pre-positioned to stimulate 40 key muscle groups. The suit comes in different sizes. A trained medical staff pre-programs which nerves/muscles to be stimulated based on a clinical assessment of the user and the outcome is evaluated through standardized methods. The stimulation program is thus specific to each user.

OTHERUsual Care

The rehabilitation therapy that is being offered at the National MS Center Melsbroek, but somewhat reduced/adjusted to make time for initiation and follow-up of using the neuromodulation suit and potentially also during the weeks at home (i.e., rehabilitation being offered by municipalities).

Locations(2)

Nationaal MS Center Melsbroek

Steenokkerzeel, Belgium

The Danish MS Hospitals

Ry, Denmark

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NCT07202195

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