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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
Who can join
Ages 18 to 75 · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Age 18 to 75 years old 2. Medical clearance from physician 3. Individuals who experience spasticity, pain, or hyperreflexia due to neurological or neuromuscular conditions or individuals with a diagnosis of Multiple Sclerosis or Fibromyalgia 4. For participants with a diagnosis of Multiple Sclerosis: 1. having a definite diagnosis for at least one month 2. Ability to walk independently or with the need of support (expanded disability status scale score (EDSS) \< 7). 3. Absence of relapses in the last three months 4. Demonstrating spasticity with a score of at least 1+ on the Modified Ashworth Scale (MAS) 5. Berg Balance Scale (BBS) score of ≤ 46 (associated in the literature with a risk of fall) 5. For participants with a diagnosis of Fibromyalgia: a. having a definite diagnosis for at least three months 6. Able to follow instructions and inform study staff of pain and/or discomfort 7. Able to ambulate 10m without body weight support with or without assistive devices and/or caregiver assistance Exclusion Criteria: 1. Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts) 2. Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used 3. No established somatic or neuropsychiatric diagnosis prior to enrollment in the study 4. Pregnant and/or nursing
About the study
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.
What is being tested
- Active full-body stimulation (device)
- Sham full-body stimulation (other)
Sponsor: Shirley Ryan AbilityLab · Participants: 15 · Started: Jul 23, 2025
Contact the study team
- Arun Jayaraman, PhD · Phone: 312-238-6875
- Sara Prokup, DPT · Phone: 312-238-1355
Official record on ClinicalTrials.gov — NCT07132775
Locations in the U.S.
| Illinois | Shirley Ryan AbilityLab, Chicago |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.