Neuro20 electrical stimulation suit to improve autonomic control, muscle performance, and walking after amputation or neurologic injury
Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brooks Rehabilitation Academic / other |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT07164846 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Jacksonville, Florida and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.