EXOPULSE Mollii full-body electrostimulation for spasticity, hyperreflexia, and pain
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
This project will see if wearing the EXOPULSE Mollii full-body electrostimulation suit daily for 60 minutes over 12 weeks helps reduce spasticity, hyperreflexia, or pain in adults with neurological or neuromuscular conditions such as multiple sclerosis or fibromyalgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT07132775 on ClinicalTrials.gov |
What this trial studies
The trial tests the EXOPULSE Mollii full-body electrostimulation suit in adults who experience spasticity, hyperreflexia, or pain from neurological or neuromuscular conditions. Participants will follow a protocol to optimize device fitting and outcome collection, then complete daily 60-minute sessions for a 12-week period either in-clinic or at home, with some receiving active stimulation and others receiving sham stimulation. Up to 15 participants will complete portions or all procedures to refine the fitting, in-clinic and at-home protocols, and assessment timing. Safety, tolerability, and changes in standardized spasticity and pain measures will be recorded at scheduled visits.
Who should consider this trial
Good fit: Adults aged 18–75 with neurological or neuromuscular conditions (including multiple sclerosis or fibromyalgia) who experience spasticity, hyperreflexia, or pain, can ambulate about 10 meters, and have medical clearance are the ideal candidates.
Not a fit: People without measurable spasticity or pain, those with recent MS relapses, or individuals with severe mobility limitations (for example EDSS ≥7) are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If effective, the device could reduce spasticity and pain and improve daily function and comfort for people with MS, fibromyalgia, or other neuromuscular conditions.
How similar studies have performed: Small pilot studies and case series of the Mollii suit and related neuromodulation garments have reported symptomatic improvements in spasticity and pain, but large randomized data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Arun Jayaraman, PhD
- Email: ajayaraman@sralab.org
- Phone: 312-238-6875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.