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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Battelle Memorial Institute | OTHER |
| Congressionally Directed Medical Research Programs | FED |
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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.
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 electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. This allows users to attempt a movement and, even in the absence of physical movement, the system can detect what they are trying to do and electrically stimulate the muscles they are attempting to use. We hypothesize that this ability to control the system with participant's own muscle signals will assist in improving and restoring hand function of SCI survivors with tetraplegia. Furthermore, preliminary studies have suggested the potential for motor-intention driven FES to promote functional recovery after system use. With the dual-purpose use as a functional orthosis and as a rehabilitation tool for restoration of hand function, the NeuroLife EMG-FES System is poised to transform the state of care for those with hand impairment due to SCI.
The overarching goal of this proposal is to investigate the safety, feasibility, and early efficacy of the NeuroLife EMG-FES system on upper extremity outcomes in chronic SCI survivors with tetraplegia. A pilot clinical trial will allow us to test the following aims: Aim 1. Determine the early efficacy of using the NeuroLife EMG-FES System as a functional orthosis to complete functional activities after 12 weeks of task practice using the system. Aim 2. Determine the early efficacy of using the NeuroLife EMG-FES System as a rehabilitation tool to improve sensorimotor function after 12 weeks of task practice using the system. Aim 3. Develop and establish EMG-based biomarkers of neuroplasticity and recovery after chronic SCI.
We plan to conduct a pilot clinical trial investigating the NeuroLife EMG-FES Sleeve System 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 of participants and has up to 160 electrodes that can record electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. Using this combined, closed-loop technology participants will complete a 12-week protocol with a study therapist practicing functional activities using their hand/forearm while wearing the NeuroLife EMG-FES Sleeve System. We will assess functional outcomes using standardized clinical measures at 6 timepoints (double baseline, 4 weeks, 8 weeks, post-intervention, and 4 weeks post-intervention). At these timepoints we will also collect high-definition EMG data using the NeuroLife EMG-only system to investigate the ability to use EMG as a biomarker of recovery over time in chronic SCI participants undergoing rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroLife EMG-FES Sleeve System | Experimental | 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 electromyography (EMG), or muscle activity, and also electrically stimulate (FES) muscles. Using this combined, closed-loop technology participants will complete a 12-week protocol with a study therapist practicing functional activities using their hand/forearm while wearing the NeuroLife EMG-FES Sleeve System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeuroLife EMG-FES Sleeve System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 1: Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) (Object Manipulation Subtest) | Evaluation of object manipulation while simulating 10 ADL tasks. | baseline to 4-week post-intervention follow-up |
| Aim 2: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2 | Gold standard for measuring neurologic recovery and hand function across sensation, strength, prehension ability, and prehension performance. | baseline to 4-week post-intervention follow-up |
| Aim 3: Grasp and Release Test (GRT) | Measurement of EMG derived biomarkers while attempting movements from the GRT. | baseline to 4-week post-intervention follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Aim 1: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2 (Prehension Performance Subtest) | Measures ability to perform ADL-based tasks using different grasps. | baseline to 4-week post-intervention follow-up |
| Aim 2: Spinal Cord Independence Measure (SCIM)-III |
| Measure | Description | Time Frame |
|---|---|---|
| Expedited International Standards for Neurological Classification of SCI (E-ISNCSCI) | Expedited International Standards for Neurological Classification of SCI (E-ISNCSCI) to determine neurologic level of injury and ASIA score. | baseline to 4-week post-intervention follow-up |
| Tetraplegia Upper Limb Activities Questionnaire (TUAQ) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Wengerd, PhD | Ohio State University | Principal Investigator |
| David Friedenberg, PhD | Battelle Memorial Institute | Principal Investigator |
| Peyton Miller, OTD | Ohio State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Battelle Memorial Institute | Columbus | Ohio | 43201 | United States | ||
| Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2026 | Apr 1, 2026 |
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Participants with chronic cervical spinal cord injury will complete a 12-week intervention protocol (3x/week) in an outpatient setting where they will practice functional activities using their hand/forearm while wearing the NeuroLife EMG-FES Sleeve System. We will assess functional outcomes using standardized clinical measures at 6 timepoints (double baseline, 4 weeks, 8 weeks, post-intervention, and 4 weeks post-intervention).
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We will have an independent outcome rater conduct assessments who is not involved in the intervention, however, because this is a single-arm trial there is no way to truly 'mask' the assessor.
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Patient-reported ADL participation across 3 domains: self-care, respiration and sphincter management, & mobility. |
| baseline to 4-week post-intervention follow-up |
A 10-item, 5-response patient-reported outcome measure assessing performance and satisfaction with UE activities for individuals with tetraplegia. |
| baseline to 4-week post-intervention follow-up |
| Demographics/History | Self-report: Age, SCI history, caregiver support, etc. | baseline |
| Grasp and Release Test (full) | Evaluates hand function, specifically the ability to grasp, move, and release various objects. | from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment |
| Action Research Arm test (ARAT) | Assesses upper limb function with grasp, grip, pinch, and gross motor movements through a series of timed tasks involving everyday objects | from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment |
| Goniometry | Measures joint range of motion (ROM) using a goniometer. | from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment |
| Dynamometry | Measures grip strength, using a handheld device called a dynamometer. | from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment |
| Pinch Gauge | Measures pinch strength | from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment |
| Columbus |
| Ohio |
| 43210 |
| United States |
| ICF_002.pdf |