At Home Use of Stimulation Suits for Managing MS Symptoms

NCT07202195 | Recruiting

• 1 other identifier: J5812540_2024
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 2

Brief 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

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

Keywords

ataxia; spasticity; multiple sclerosis; MS; neuromodulation suit; stimulation suit; exopluse molli suit; home-based rehabilitation; symptom management

Outcome Measures

Primary Outcomes (1)

• NHPT+SSST score

  The primary outcome will be a combined measure of upper and lower extremity motor function, consisting of the Nine Hole Peg Test and the Six Spot step test (labelled NHPT+SSST score). Values are expressed in seconds. A higher score, indicates a worse outcome.

  After one and six weeks of stimulation for the intervention group. The control group will be assessed at the same time points.

Secondary Outcomes (14)

• Six spot step test (SSST)

  SSST assessment will take place after weeks 1 and 6 of stimulation.

• Nine Hole Peg Test (NHPT)

  NHPT assessment will take place after weeks 1 and 6 of stimulation.

• Modified Ashworth Scale (MAS)

  MAS assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.

• Scale for the Assessment and Rating of Ataxia (SARA)

  SARA assessment will take place during screening, as they are used to determine eligibility and after weeks 1 and 6 of stimulation.

• Numeric Rating Scale (NRS)

  NRS assessments will take place after weeks 1 and 6 of stimulation.

Other Outcomes (10)

• Multiple Sclerosis (MS) type

  Will be collected (at baseline) when a partcipant is found eligible

• age

  Will be collected at baseline when a partcipant is found eligible

• sex

  Will be collected at baseline when a partcipant is found eligible

Study Arms (2)

stimulation suit group

EXPERIMENTAL

This group will wear a full-body stimulation suit every day or every other day for six weeks, in addition to their usual care.

Device: electro-stimulation suit; Other: Usual Care

usual care

OTHER

This group will be a comparator and have no added intervention expect for their usual care.

Other: Usual Care

Interventions

electro-stimulation suit DEVICE

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.

Also known as: neuromodulation suit, stimulation suit, EXOPULSE MOLLII suit

stimulation suit group

Usual Care OTHER

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).

Also known as: standard care

stimulation suit group; usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have the cognitive abilities to understand instructions and to be able to complete the questionnaires adequately
• Diagnosis of multiple sclerosis.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: collaborator
• National MS Center Melsbroek: collaborator
• Daphne Kos: lead
• Danish MS Hospitals, Haslev and Ry: collaborator

Study Sites (2)

Nationaal MS Center Melsbroek

Steenokkerzeel, 1820, Belgium

RECRUITING

The Danish MS Hospitals

Ry, 8680, Denmark

RECRUITING

Related Publications (26)

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  BACKGROUND

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MeSH Terms

Conditions

Multiple Sclerosis; Cerebellar Ataxia; Ataxia; Muscle Spasticity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Daphne Kos

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daphne Kos

CONTACT

+32496107849; daphne.kos@uzbrussel.be

Alix-Anne Schreinemacher

CONTACT

alix-anne.schreinemacher@mscenter.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: October 1, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); DK (1)