Skip to main content
OpenTrials
Completed

NCT Number: NCT06087445

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Spinal Cord Injury

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Battelle Memorial Institute, Columbus, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Demographics/History

    Time frame: baseline

    Self-report: Age, SCI history, caregiver support, etc.

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. Pinch Gauge

    Time frame: from 4 weeks after enrollment and end of 12 weeks +/- 2 weeks treatment

    Measures pinch strength

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

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

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 17, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.