NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07132775

RecruitingNA

Sponsor: Shirley Ryan AbilityLab

Conditions: Multiple Sclerosis, Fibromyalgia, Neurologic Disorder, Neuromuscular Disorders

Interventions: Active full-body stimulation, Sham full-body stimulation

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Chicago, Illinois, United States