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

NCT ID: NCT07164846

Last Updated: 2025-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-08-01

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.

Detailed Description

The purpose of this research study is to study the effect of the Neuro20 Functional Electrical Stimulation Suit on autonomic function, muscle performance, and walking ability. Electrical stimulation is intended to stimulate muscles in order to improve muscle performance. The Neuro20 is approved for this use by the United States Food and Drug Administration. In this study, the use of the device is considered investigational. Twenty subjects will participate in this study.

Conditions

Spinal Cord Injury; Stroke; Amputees

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Suit Stimulation

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.

Group Type: EXPERIMENTAL

Therapy Sessions

Intervention Type: 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.

Interventions

Therapy Sessions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brooks Rehabilitation

OTHER

Sponsor Role: lead

Responsible Party

mark.bowden

Vice President of Clinical Integration and Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Bowden, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Brooks Rehabilitation

Locations

Brooks Rehabilitation

Jacksonville, Florida, United States

Site Status: RECRUITING

The International Institute of Orthotics and Prosthetics

Tampa, Florida, United States

Site Status: NOT_YET_RECRUITING

Countries

United States

Central Contacts

Hannah Grimes

Role: CONTACT

hannah.grimes@brooksrehab.org

904-597-3478

Facility Contacts

Hannah Grimes

Role: primary

hannah.grimes@brooksrehab.org

904-528-3159

Mike Hoggatt

Role: primary

mhoggatt@iiop.edu

601-720-7291

Other Identifiers

Pro00083882

Identifier Type: -

Identifier Source: org_study_id