A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
Ohio State University
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.
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 injury (SCI) using the NeuroLife EMG-FES System, and that EMG can be used to discriminate multiple attempted hand movements to drive continuous control of functional electrical stimulation (FES). Briefly, the NeuroLife EMG-FES System is a completely non-invasive system (surface electrodes only, no implantable components) worn on the forearm of participants and has up to 160 electrodes that can record…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 pro…
Interventions
- DeviceNeuroLife EMG-FES Sleeve System
Participants will complete a 12-week training protocol (3x/week, 1-2 hours/session) which includes an activity-based upper extremity training paradigm where participants will complete multiple repetitions attempting functional tasks in different categories (grip, grip with rotation, pinch, and pinch with rotation) while using the closed-loop EMG-FES system on one forearm/hand. Each category includes \~10 functional tasks (e.g., grip - open a jar; pinch with rotation - nuts and bolts) that progressively increase in difficulty. Each session will include massed practice of 3 functional tasks (20-minute blocks for each task) with rest breaks as needed to avoid fatigue. Sessions will include \~60 minutes of task practice, but they may last 1-2 hours to account for setup time and rest breaks.
Locations (2)
- Battelle Memorial InstituteColumbus, Ohio
- Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)Columbus, Ohio