RECRUITINGINTERVENTIONAL

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DEVICE

electro-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.

OTHER

Usual 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