At Home Use of Stimulation Suits for Managing MS Symptoms

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.

Conditions

• Multiple Sclerosis
• MS (Multiple Sclerosis)
• Spasticity With Multiple Sclerosis
• Ataxia - Other
• Ataxia, Cerebellar
• Ataxia, Motor
• Spasticity
• Home Based Care

Interventions

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).

Sponsors & Collaborators

• Danish MS Hospitals, Haslev and Ry

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• National MS Center Melsbroek

  collaborator OTHER

• Daphne Kos

  lead OTHER

Principal Investigators

• Daphne Kos · Universitair Ziekenhuis Brussel

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-31

Primary Completion

2027-09-30

Completion

2027-09-30

Countries

• Belgium
• Denmark

Study Locations