Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07202195

At Home Use of Stimulation Suits for Managing MS Symptoms

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

70

Participants Needed

2

Research Sites

78 weeks

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

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

Official 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...

  • Have multiple sclerosis diagnosis
  • Experience ataxia (SARA score 5) or spasticity (MAS score 1)
  • Have impairments in upper or lower limb physical function
  • Able to understand instructions and complete questionnaires adequately
Not Eligible

You will not qualify if you...

  • Have implanted devices such as pacemaker, Baclofen pump, neurostimulator, defibrillator, shunts, ECG equipment, electronic life support, or high frequency operation equipment
  • Changed disease modifying treatment within the last 3 months
  • Used Botulinum Toxin A within the last 3 months
  • Had a relapse in the last 3 months
  • Have acute musculoskeletal problems that hinder test performance
  • Are pregnant
  • Require stimulation suit size larger than 3XL
  • Have skin eruptions or swollen, infected, or inflamed areas in the stimulation zone

AI-Screening

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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

CONTACT

A

Alix-Anne Schreinemacher

CONTACT

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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