Evaluation of the Safety and Efficacy of a Full-Body Electrostimulation Garment for Individuals With Neurological and Neuromuscular Conditions That Cause Spasticity, Hyperreflexia, and Pain
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Multiple Sclerosis, Fibromyalgia, Neurologic Disorder, Neuromuscular Disorders
In brief
The purpose of this study is to to explore the safety and efficacy of the EXOPULSE Mollii suit, a full-body electrostimulation suit, for individuals with neurological or neuromuscular conditions that cause spasticity, hyperreflexia, and/or pain.
Key facts
- Study ID
- NCT07132775
- Run by
- Shirley Ryan AbilityLab
- People needed
- 15
- Starts
- 2025-07-23
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2025-09-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 75 years old
- Medical clearance from physician
- Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia
- For participants with a diagnosis of Multiple Sclerosis:
- having a definite diagnosis for at least one month
- Ability to walk independently or with the need of support (expanded disability status scale score (EDSS) < 7).
- Absence of relapses in the last three months
- Demonstrating spasticity with a score of at least 1+ on the Modified Ashworth Scale (MAS)
- Berg Balance Scale (BBS) score of < 46 (associated in the literature with a risk of fall)
- For participants with a diagnosis of Fibromyalgia:
- a. having a definite diagnosis for at least three months
- Able to follow instructions and inform study staff of pain and/or discomfort
- Able to ambulate 10m without body weight support with or without assistive devices and/or caregiver assistance
You may not qualify if…
- Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)
- Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used
- No established somatic or neuropsychiatric diagnosis prior to enrollment in the study
- Pregnant and/or nursing
Where it is running
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (enrolling)
Full record on ClinicalTrials.gov
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