NCT07132775 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
| NCT ID | NCT07132775 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shirley Ryan AbilityLab |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-07-23 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07132775 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07132775 currently recruiting?
Yes, NCT07132775 is actively recruiting participants. Contact the research team at ajayaraman@sralab.org for enrollment information.
Where is the NCT07132775 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT07132775 clinical trial?
NCT07132775 is sponsored by Shirley Ryan AbilityLab. The trial plans to enroll 15 participants.
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