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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe the EXOPULSE Mollii suit is and how well it works. This full-body suit uses electrical stimulation. It is for people with nerve or muscle conditions that cause stiff muscles, overly strong reflexes, or pain, including people with multiple sclerosis or fibromyalgia.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 75 years old and have a doctor's approval to join.
  • Have stiff muscles, pain, or overly strong reflexes from a nerve or muscle condition, or have multiple sclerosis (MS) or fibromyalgia.
  • If you have MS, have a confirmed diagnosis for at least 1 month and no flare-ups in the past 3 months.
  • If you have MS, be able to walk alone or with support, with an EDSS disability score below 7.
  • If you have MS, have muscle stiffness rated at least 1+ on the Modified Ashworth Scale and a balance test score of 46 or less, which suggests a risk of falling.
  • If you have fibromyalgia, have a confirmed diagnosis for at least 3 months.
  • Be able to follow instructions and tell study staff about pain or discomfort.
  • Be able to walk 10 meters without equipment holding up your body weight. Walking aids or help from a caregiver are allowed.

Who can't join

  • Have a medical device or equipment inside your body that magnets could affect, such as a shunt.
  • Have swollen, infected, or inflamed areas, skin rashes, or vein problems where the suit will be used.
  • Do not have an established diagnosis of a physical health, brain, or mental health condition before joining.
  • Are pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

IL