Neuro20 electrical stimulation suit to improve autonomic control, muscle performance, and walking after amputation or neurologic injury
Official title: Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait
Run by Brooks Rehabilitation · NCT07164846 · Data updated 2026-11-12
This will test whether wearing the Neuro20 electrical stimulation suit helps people at least one week after an amputation or neurologic injury (stroke, spinal cord injury, or brain injury) improve autonomic function, muscle strength, and walking.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Brooks Rehabilitation Academic / other |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Status | Recruiting |
| Started | August 5, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT07164846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are medically stable adults at least one week post-amputation or neurologic injury who can provide informed consent and follow a three-step command.
✕Probably not a fit
People with pacemakers or other implanted devices that cannot be turned off, uncontrolled seizures, active infection or fever, significant wounds in stimulated areas, severe cardiac disease, pregnancy, bleeding disorders, or inability to follow commands are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study will enroll 20 participants who are medically stable at least one week after an amputation or neurologic injury. Participants will wear the FDA-cleared Neuro20 functional electrical stimulation suit during supervised therapy sessions while investigators deliver patterned electrical stimulation to targeted muscles. Outcomes measured before and after the intervention will include autonomic nervous system metrics, muscle performance tests, and gait analysis. The device is approved by the FDA for this use but is being tested as an investigational intervention in this protocol at two Florida sites.
Why it matters
Potential benefit: If successful, the Neuro20 suit could improve autonomic regulation, muscle strength, and walking ability for people after amputation or neurologic injury.
How similar studies have gone: Functional electrical stimulation approaches have shown benefits for muscle strength and gait in prior stroke and spinal cord injury research, but the Neuro20 suit itself is relatively new and less widely studied.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Brooks Rehabilitation
Jacksonville, Florida, United States Recruiting -
The International Institute of Orthotics and Prosthetics
Tampa, Florida, United States Not yet recruiting
Study contacts
- Principal investigator: Mark Bowden, PT, PhD — Brooks Rehabilitation
- Study coordinator: Hannah Grimes
- Email: hannah.grimes@brooksrehab.org
- Phone: 904-597-3478
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.