Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait

NCT07164846 | Recruiting FDA Device

• 1 other identifier: Pro00083882
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This research aims to understand the effect of the Neuro20 Functional Electrical Stimulation Suit on autonomic nervous system function, muscle performance, and gait after amputation or neurologic injury.

Conditions

Spinal Cord Injury; Stroke; Amputees

Outcome Measures

Primary Outcomes (1)

• Change in Gait

  The 6-minute walk test is a simple, standardized test used to assess a person's exercise capacity and functional mobility. An increase in distance walked reflects an improvement in mobility and gait.

  Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks

Secondary Outcomes (1)

• Change in Autonomic Function

  Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks

Study Arms (1)

Active Suit Stimulation

EXPERIMENTAL

Participants will be engaging in one hour of therapy with the suit in stimulation mode for twelve sessions. The first three sessions will be in conditioning mode, and the subsequent nine will be in strength mode.

Device: Therapy Sessions

Interventions

Therapy Sessions DEVICE

You will complete up to 12 sessions using the Neuro20 suit under the direct supervision of study staff. Each session will be 1-2 hours in duration. Each session, you will change into the suit and then receive no more than 105 minutes of electrical stimulation, and then change out of the suit and have a skin check. The suit has 20 electrodes that will stimulate muscles in your upper arm (above the elbow), upper leg (above the knee), chest, abdominals, and back. Stimulation levels will be adjusted to your comfort. You will likely feel tingling and/or muscle contractions. The timing and intensity of each type of activity will depend on your individual needs and will be prescribed by the study doctor.

Active Suit Stimulation

Eligibility Criteria

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

You may qualify if:

• At least one week post amputation or neurologic injury (i.e. brain injury, stroke, spinal cord injury) and deemed medically stable to participate in rehabilitation
• Able to provide Informed Consent by demonstrating the ability to follow a three step command

You may not qualify if:

• Pacemaker / Defibrillator or severe cardiac disease (Class IV according to New York Heart Association Functional Classification)
• Implanted medical devices
• Active DVT/thrombophlebitis
• Active Cancer
• Active fever, infection, or acute inflammation
• Pregnancy
• Epilepsy or uncontrolled seizures or seizure within the last 6 months
• Implanted stimulator or pump that cannot be turned off externally
• Significant, active wounds in areas stimulated by the suit
• Inability to follow a three-step motor command
• Bleeding tendency

Sponsors & Collaborators

• Brooks Rehabilitation: lead

Study Sites (2)

Brooks Rehabilitation

Jacksonville, Florida, 32216, United States

RECRUITING

The International Institute of Orthotics and Prosthetics

Tampa, Florida, 33634, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark Bowden, PT, PhD

  Brooks Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Grimes

CONTACT

904-597-3478; hannah.grimes@brooksrehab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Clinical Integration and Research

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: September 10, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (2)