Overview
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.
Description
Optimization Aim: Identify a systematic, methodological approach to device fitting, inclinic and at-home protocols using the Mollii suit, and optimization of collecting outcome measures at assessment visits. For example, up to 15 participants will complete a portion or all of the procedures listed in the "Procedures Involved" section of this protocol to determine an optimal approach.
Aim 1: Assess the safety of the Mollii suit during an in-clinic or at-home 12-week period consisting of daily sessions of a 60-minute duration in individuals with pain and/or spasticity from neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.
Aim 2: Evaluate the use of full-body active electrostimulation as compared to full-body sham electrostimulation as an intervention in-clinic or at-home for individuals experiencing pain and/or spasticity due to neurological and neuromuscular conditions that cause spasticity, hyperreflexia, and pain.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Implanted medical devices or equipment which can be disrupted by magnets (ex. Shunts)
- Swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins, etc.) in areas where the suit will be used
- No established somatic or neuropsychiatric diagnosis prior to enrollment in the study
- Pregnant and/or nursing