RecruitingNot ApplicableNCT07164846

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

Sponsor

Brooks Rehabilitation

Enrollment

30 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke Spinal Cord Injury Amputees

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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 Criteria11

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

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Interventions

DEVICETherapy 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.