Effect of Neuro20 Functional Electrical Stimulation Suit on Autonomic Function, Muscle Performance, and Gait
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Therapy Sessions.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury, Stroke, Amputees. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Device Therapy 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
Primary outcome measures
- Change in Gait [Time frame: Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks]
Secondary outcome measures (1)
- Change in Autonomic Function [Time frame: Pre-intervention, mid-intervention at 1 week, and post-intervention at 4 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Brooks Rehabilitation — Jacksonville
- The International Institute of Orthotics and Prosthetics — Tampa
Identifiers
NCT: NCT07164846 · Pro00083882