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NCT07132775Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
15 (estimated)
First submitted
23 Jul 2025
Start date
23 Jul 2025
Primary completion date
Jul 2027
Lead sponsor
Shirley Ryan AbilityLab
NCT number
NCT07132775

What you commit to

  • Study type: Interventional
  • Planned participants: 15
  • From 23 Jul 2025 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No established somatic or neuropsychiatric diagnosis prior to enrollment in the study

Other illness

  • Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used

Other

  • Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)
  • Pregnant and/or nursing

Who the study is looking for

  • 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:
    • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shirley Ryan AbilityLab
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.