Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07202195

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

Led by Daphne Kos · Updated on 2026-02-06

70

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

D

Daphne Kos

Lead Sponsor

D

Danish MS Hospitals, Haslev and Ry

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying whether wearing a full-body electrical stimulation suit at home can help people with Multiple Sclerosis (MS) who experience muscle stiffness (spasticity) or poor coordination (ataxia). The study compares two groups: one using the stimulation suit alongside their usual care, and a control group receiving only their usual care. The purpose is to see if the suit reduces symptoms and improves daily functioning over six weeks. Participants in the intervention group will wear the tailored electro-stimulation suit daily or every other day for six weeks, starting with one week at an MS center and continuing five weeks at home. The suit delivers low-energy electrical pulses to key muscle groups and is programmed specifically for each user by trained medical staff. The control group will receive their usual rehabilitation care without the suit. Participants will undergo clinical tests at the MS center after one week and six weeks, including various physical and functional assessments like walking tests and muscle function scales. The study also collects weekly symptom ratings during the intervention. Researchers will measure changes in coordination, muscle stiffness, and overall physical ability, with safety monitoring throughout. The total participation lasts six weeks with scheduled evaluations.

CONDITIONS

Brief Title

At Home Use of Stimulation Suits for Managing MS Symptoms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosis of multiple sclerosis
  • Presence of ataxia with a SARA score of 4 or higher, or spasticity with a MAS score of 1 or higher
  • Ability to understand instructions and complete questionnaires adequately
Not Eligible

You will not qualify if you...

  • Presence of implanted medical devices such as pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, or high frequency operation equipment
  • Change in disease modifying treatment within the last 3 months
  • Use of Botuline Toxine A within the last 3 months
  • Recent relapse within the last 3 months
  • Acute musculoskeletal problems that prevent test performance
  • Pregnancy
  • Body size larger than 3XL (triple extra large)
  • Skin eruptions or swollen, infected, or inflamed skin areas in the stimulation zone

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Implementation

Duration - 6 weeks

Participants in the stimulation suit group will wear a full-body neuromodulation suit every day or every other day for six weeks, in addition to their usual care. Participants in the usual care group will continue with their rehabilitation therapy without additional intervention.

Visits at week 1 and week 6 for assessments; weekly symptom assessments during the 6 weeks

Trial Site Locations

Total: 2 locations

1

Nationaal MS Center Melsbroek

Steenokkerzeel, Belgium, 1820

Actively Recruiting

2

The Danish MS Hospitals

Ry, Denmark, 8680

Actively Recruiting

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Research Team

D

Daphne Kos

A

Alix-Anne Schreinemacher

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Validity and variability of the 5-repetition sit-to-stand test in patients with multiple sclerosis.

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