At Home Use of Stimulation Suits for Managing MS Symptoms (HANDS-MS)

Daphne Kos

Status: Enrolling

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

Treatments: Device: electro-stimulation suit; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07202195

J5812540_2024

Details and patient eligibility

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

stimulation suit group

Experimental group

Description:

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

Treatment:

Other: Usual Care

Device: electro-stimulation suit

usual care

Other group

Description:

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

Treatment:

Other: Usual Care