EXOPULSE Suit to improve walking in people with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The EXOPULSE Suit is a non-invasive wearable garment with 50 electrodes that can stimulate up to 43 major muscle groups to reduce spasticity and support balance. In this interventional study, people with MS and moderate disability (EDSS 4–6) will use the suit at home for one hour every other day and outcomes will focus on walking ability. Participants will use the suit in active or sham modes so the effects of the electrical stimulation can be compared. The trial is being run at three French centers and targets people who cannot or prefer not to use fampridine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Person with a clear Multiple Sclerosis diagnosis according to the 2017 revision of the McDonald criteria since at least 3 months.
* Person with an Expanded Disability Status Scale (EDSS) score ≥ 4 and ≤ 6
* Person with stable walking ability for at least two weeks prior to the inclusion visit (variation at the MSWS-12 questionnaire \< 8/100 points)
* Person not treated with fampridine due to contra-indication or adverse events or not respondent or no longer respondent or reluctant to taking drugs
* Person with spasticity at the lower limb(s), attested by a Modified Ashworth Scale ≥ 1+ of at least one of the following muscle groups: quadriceps, hamstrings, triceps surae, tibialis anterior
* Person who never tried EXOPULSE SUIT

Exclusion Criteria:

* Person under 18 years old
* Person having a contraindication to using EXOPULSE SUIT
* Person using an electronic life-support equipment, e.g. pacemakers or hight-frequency surgical equipment and person using an ECG equipment
* Person affected by other somatic or neuropsychiatric diagnoses (e.g., arrhythmias, uncontrolled epilepsy, diseases causing osteoarticular and muscular pain).
* Person with relapses over the last 3 months before the inclusion
* Person who had a modification of his/her medical treatments of the multiple sclerosis or related to motor performance over the last 3 months before the inclusion
* Person who had a new medical treatment of the multiple sclerosis or related to motor performance over the last 3 months before the inclusion
* Person who had an injection of botulinum toxin in at least one of the main muscle groups of the lower limbs over the last 4 months before the inclusion
* Person planning to use a new medical device during the study (ex: ankle-foot orthosis…)
* Person undergoing or planning to undergo an intensive rehabilitation phase
* Person that is part of another study
* Person who cannot be fitted with EXOPULSE SUIT due to inexistent Suitable size of the Suit (eg: BMI\>35; user height \< 100 cm or \> 205cm)
* Person who does not have a smartphone or who cannot or does not want to use his/her smartphone for operating the EXOPULSE App
* Person not available to undergo all medical visits during the study
* Person unable to understand verbal and written instructions in french
* Pregnant person
* Persons under juridical protection
* Prisoners

Where it's running

• Centre Jacques Calvé Fondation Hopale
  Berck, France Recruiting
• CHU Henri Mondor
  Créteil, France Recruiting
• CHU Dijon
  Dijon, France Recruiting
• Clinique Verdaich
  Gaillac-Toulza, France Recruiting
• Hôpital Raymond-Poincaré
  Garches, France Recruiting
• Centre Médical Germaine REVEL
  Lyon, France Recruiting

Study contacts

• Study coordinator: Aurelie LACROIX, Ing.
• Email: aurelie.lacroix@ottobock.com
• Phone: 0033 (0)7 86 29 52 03

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cooling During Inpatient Rehab for People with MS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.