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 | Recruiting FDA Device

• 1 other identifier: STU00221544
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Fibromyalgia; Neurologic Disorder; Neuromuscular Disorders

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  The Berg Balance Scale is a 14-item objective measure that assesses static balance and falls risk. The functional abilities that are assessed include sitting and standing balance, transfers, altered bases of support, reaching, turning, and closing eyes.Scores range from 0 - 56, with higher scores indicating improved balance.

  Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

Secondary Outcomes (9)

• Manual Muscle Test

  Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

• Modified Ashworth Scale

  Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

• 10 Meter Walk Test

  Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

• 6 Minute Walk Test

  Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

• Timed Up and Go

  Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after 2 weeks of Arm 1)- at approx 2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at approx 4 weeks, Endpoint 2 (after 2 weeks of Arm 2)- at approx 6 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Device: Active full-body stimulation

Sham

SHAM COMPARATOR

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

Other: Sham full-body stimulation

Interventions

Active full-body stimulation DEVICE

Participants will receive active stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

Intervention

Sham full-body stimulation OTHER

Participants will receive sham stimulation through a full-body suit with embedded electrodes that deliver a low-grade electrical stimulation to muscle groups.

Sham

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• a. 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Otto Bock Healthcare Products GmbH: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Fibromyalgia; Nervous System Diseases; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Arun Jayaraman, PhD

CONTACT

312-238-6875; ajayaraman@sralab.org

Sara Prokup, DPT

CONTACT

312-238-1355

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director - Max Nader Center for Rehabilitation Technologies and Outcomes Research

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 20, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)