Recruiting

Neuro20

Sponsor:

Brooks Rehabilitation

Code:

NCT07164846

Conditions

Spinal Cord Injury

Stroke

Amputees

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Therapy Sessions

Study Details

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

Study ID

NCT07164846

Start date

Aug 5, 2025

Status verified date

Oct, 2025

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Change in Gait [ Time Frame: Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks ]

Central Contacts and Locations

Central contacts

Hannah Grimes

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

Locations

Brooks Rehabilitation

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Hannah Grimes

904-528-3159hannah.grimes@brooksrehab.org

Principal Investigator:

Mark Bowden

More Information

Sponsor

Brooks Rehabilitation

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brooks Rehabilitation on 2025-10-31.