Recruiting

EXOPULSE Mollii Suit

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT07132775

Conditions

Multiple Sclerosis

Fibromyalgia

Neurologic Disorder

Neuromuscular Disorders

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Active full-body stimulation

Sham full-body stimulation

Study Details

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

Study ID

NCT07132775

Start date

Jul 23, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

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

sham comparator: Sham

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

Interventions

Active full-body stimulation

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

Sham full-body stimulation

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

Primary outcome measure

  • Berg Balance Scale [ Time Frame: Baseline 1 (prior to Arm 1)- initial visit, Endpoint 1 (after Arm 1)- at ~2 weeks, Baseline 2 (after 2 week washout and before Arm 2)- at ~4 weeks, Endpoint 2 (after Arm 2)- at ~6 weeks, Follow-Up (2 weeks after Endpoint 2)- at ~8 weeks ]

Central Contacts and Locations

Central contacts

Sara Prokup, DPT

312-238-1355

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sara Prokup

312-238-1355

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-08-28.