A non-invasive device to help restore hand function in tetraplegic patients
A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
This study is testing a new device that helps people with paralysis in their arms and hands regain some movement and control through electrical stimulation over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Ohio State University Academic / other |
| Locations | 2 sites (Columbus, Ohio and 1 other locations) |
| Trial ID | NCT06087445 on ClinicalTrials.gov |
What this trial studies
This pilot clinical study investigates the NeuroLife EMG-FES Sleeve System, a non-invasive device designed to restore grasp functions in adults with chronic tetraplegia due to cervical spinal cord injury. The system utilizes surface electrodes to record muscle activity and provide electrical stimulation, allowing users to control movements even without physical motion. Participants will engage in a rehabilitation protocol over 12 weeks, attending sessions three times a week, to assess the safety, feasibility, and efficacy of the device. The study also aims to explore the potential of electromyography as a biomarker for recovery in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 years or older with chronic cervical spinal cord injuries who are unable to grasp or manipulate objects.
Not a fit: Patients with severe upper extremity spasticity, contractures, or medical contraindications to functional electrical stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hand function and independence for patients with tetraplegia.
How similar studies have performed: Preliminary studies have shown promise for similar approaches, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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 that prevent FES-evoked wrist and finger movements 5. ventilator dependent 6. pregnant or plan to become pregnant (females only) 7. actively participating in upper extremity rehabilitation.
Where this trial is running
Columbus, Ohio and 1 other locations
- Battelle Memorial Institute — Columbus, Ohio, United States (Recruiting)
- Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion) — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Lauren Wengerd, PhD — Ohio State University
- Study coordinator: Lauren Wengerd, PhD
- Email: lauren.wengerd@osumc.edu
- Phone: 330-464-9171
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.