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

Last updated: October 30, 2025
Sponsor: Brooks Rehabilitation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Spinal Cord Disorders

Stroke

Treatment

Therapy Sessions

Clinical Study ID

NCT07164846
Pro00083882
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 stepcommand

Exclusion

Exclusion Criteria:

  • Pacemaker / Defibrillator or severe cardiac disease (Class IV according to New YorkHeart 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

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Therapy Sessions
Phase:
Study Start date:
August 05, 2025
Estimated Completion Date:
August 01, 2026

Study 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.

Connect with a study center

  • Brooks Rehabilitation

    Jacksonville 4160021, Florida 4155751 32216
    United States

    Active - Recruiting

  • The International Institute of Orthotics and Prosthetics

    Tampa 4174757, Florida 4155751 33634
    United States

    Site Not Available

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