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

Shirley Ryan AbilityLab

Status: Enrolling

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

Treatments: Device: Active full-body stimulation; Other: Sham full-body stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07132775

STU00221544

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Intervention

Experimental group

Description:

Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters actively running.

Treatment:

Device: Active full-body stimulation

Sham

Sham Comparator group

Description:

Participants will wear the full-body electrostimulation garment for 60 minutes at a time, every other day, with the stimulation parameters not actively running.

Treatment:

Other: Sham full-body stimulation