Actively Recruiting
A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
Led by Ohio State University · Updated on 2026-05-05
12
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
Sponsors
O
Ohio State University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Chronic cervical spinal cord injury (more than 12 months) classified as AIS A, B, C, or D and medically stable
- Unable to grasp and manipulate objects independently for daily activities
- Retain voluntary ability to move shoulder and elbow on one side, independently or with mobile arm support
- Willing and able to attend study sessions in Columbus, Ohio three times per week for 12 weeks plus all assessment sessions
- Able to provide informed consent
You will not qualify if you...
- Medical contraindications to functional electrical stimulation such as pacemaker or implanted devices, uncontrolled seizures, cancer, or open wounds on hands
- Severe, uncontrolled autonomic dysreflexia
- Medical conditions that may affect safety or study results as judged by the principal investigator
- Severe upper extremity spasticity or contractures preventing wrist and finger movements with FES
- Ventilator dependent
- Pregnant or planning to become pregnant (females only)
- Actively participating in upper extremity rehabilitation
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Battelle Memorial Institute
Columbus, Ohio, United States, 43201
Actively Recruiting
2
Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
L
Lauren Wengerd, PhD
CONTACT
D
David Friedenberg, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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