NCT06087445 A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
| NCT ID | NCT06087445 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Cervical Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2026-08-31 |
Trial Parameters
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Brief Summary
The goal of this pilot clinical study is to investigate the NeuroLife EMG-FES Sleeve System, a closed-loop approach to functional electrical stimulation, in adults (n=12) with chronic (\>12 months) tetraplegia due to spinal cord injury. Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm which has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. The main questions this study aims to answer are: 1) What is the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia, and 2) Can EMG be used as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation? Participants will complete an intensive, task-oriented rehabilitation protocol using the NeuroLife EMG-FES System (3x/week x 12 weeks) in an outpatient setting. We will assess functional outcomes using standardized clinical measures of hand and arm function at six timepoints.
Eligibility Criteria
Inclusion Criteria: 1. age 22 years or older 2. sustained a chronic (\>12 months) cervical SCI (AIS A, B, C, or D) and is currently medically stable 3. unable to grasp and manipulate objects to allow independent performance of activities of daily living (e.g., Tetraplegia) 4. retain voluntary ability to enact unilateral shoulder and elbow movements either independently or with a mobile arm support 5. Willing and able to attend study sessions in Columbus, Ohio for 12 weeks, 3x/week and all assessment sessions (4 weeks prior to and 4 weeks following 12-week intervention protocol) 6. able to provide informed consent. Exclusion Criteria: 1. medical contraindications to FES (e.g., pacemaker or other implanted devices, uncontrolled seizure disorder, cancer or open wounds on hands) 2. severe, uncontrolled autonomic dysreflexia 3. comorbid medical condition that, in the opinion of the PI, that may impact participant safety or study results 4. severe upper extremity spasticity or contractures t