A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia

May 21, 2026 updated by: Lauren Wengerd, Ohio State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Battelle Memorial Institute
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NeuroLife EMG-FES Sleeve System
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.
Device: NeuroLife 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1: Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) (Object Manipulation Subtest)
Time Frame: baseline to 4-week post-intervention follow-up
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
Time Frame: baseline to 4-week post-intervention follow-up
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)
Time Frame: baseline to 4-week post-intervention follow-up
Measurement of EMG derived biomarkers while attempting movements from the GRT.
baseline to 4-week post-intervention follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aim 1: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2 (Prehension Performance Subtest)
Time Frame: baseline to 4-week post-intervention follow-up
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
Time Frame: baseline to 4-week post-intervention follow-up
Patient-reported ADL participation across 3 domains: self-care, respiration and sphincter management, & mobility.
baseline to 4-week post-intervention follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expedited International Standards for Neurological Classification of SCI (E-ISNCSCI)
Time Frame: baseline to 4-week post-intervention follow-up
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)
Time Frame: 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
Time Frame: baseline
Self-report: Age, SCI history, caregiver support, etc.
baseline
Grasp and Release Test (full)
Time Frame: from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment
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)
Time Frame: from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment
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
Time Frame: from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment
Measures joint range of motion (ROM) using a goniometer.
from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment
Dynamometry
Time Frame: from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment
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
Time Frame: from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment
Measures pinch strength
from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

United States Department of Defense
Congressionally Directed Medical Research Programs
Battelle Memorial Institute

Investigators

  • Principal Investigator: Lauren Wengerd, PhD, Ohio State University
  • Principal Investigator: David Friedenberg, PhD, Battelle Memorial Institute
  • Study Director: Peyton Miller, OTD, Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2023

Primary Completion (Actual)

May 11, 2026

Study Completion (Actual)

May 11, 2026

Study Registration Dates

First Submitted

October 12, 2023

First Submitted That Met QC Criteria

October 12, 2023

First Posted (Actual)

October 17, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDMRP-SC210277P1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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