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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Shirley Ryan AbilityLab · Other
Who this trial is looking for
This trial is looking for individuals aged 18 to 75 who experience spasticity, pain, or muscle reflex issues due to neurological or neuromuscular conditions. Participants will wear a special electrostimulation suit to see if it helps with their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 75 years old
I have a medical clearance from my physician
I experience spasticity, pain, or hyperreflexia
I have been diagnosed with Multiple Sclerosis or Fibromyalgia
I can walk with or without assistance for 10 meters
I can follow instructions and communicate about my pain
I have a definite diagnosis of Multiple Sclerosis for at least a month
I have a definite diagnosis of Fibromyalgia for at least three months
You may not be able to join if
I have an implanted medical device that magnets can disrupt
I have swollen or infected skin in the area where the suit will be used
I do not have a prior diagnosis for my symptoms
I am pregnant or nursing
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 diagnos…
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
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