Status:
RECRUITING
A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
United States Department of Defense
Battelle Memorial Institute
Conditions:
Cervical Spinal Cord Injury
Eligibility:
All Genders
22+ years
Phase:
NA
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) te...
Detailed Description
In our prior work, members of our study team found that residual, sub-movement threshold EMG signals can be measured reliably from the forearm of chronically paralyzed individuals with spinal cord inj...
Eligibility Criteria
Inclusion
- age 22 years or older
- sustained a chronic (\>12 months) cervical SCI (AIS A, B, C, or D) and is currently medically stable
- unable to grasp and manipulate objects to allow independent performance of activities of daily living (e.g., Tetraplegia)
- retain voluntary ability to enact unilateral shoulder and elbow movements either independently or with a mobile arm support
- 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)
- able to provide informed consent.
Exclusion
- medical contraindications to FES (e.g., pacemaker or other implanted devices, uncontrolled seizure disorder, cancer or open wounds on hands)
- severe, uncontrolled autonomic dysreflexia
- comorbid medical condition that, in the opinion of the PI, that may impact participant safety or study results
- severe upper extremity spasticity or contractures that prevent FES-evoked wrist and finger movements
- ventilator dependent
- pregnant or plan to become pregnant (females only)
- actively participating in upper extremity rehabilitation.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06087445
Start Date
October 31 2023
End Date
August 31 2026
Last Update
November 24 2025
Active Locations (2)
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1
Battelle Memorial Institute
Columbus, Ohio, United States, 43201
2
Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)
Columbus, Ohio, United States, 43210