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NCT Number: NCT07164846

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooks Rehabilitation, Jacksonville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Gait

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

    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.

Secondary outcomes

  1. Change in Autonomic Function

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

    Heart rate variability measures the variation in time between individual heartbeats, not just the average heart rate. An increase in variabiility indicates better health.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Grimes

CONTACT

[email protected]

904-597-3478

Sponsors and collaborators

Lead sponsor

Brooks Rehabilitation

Other

Registry information

Acronym: Neuro20

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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