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

NCT06087445 | Recruiting DMC FDA Device

• 1 other identifier: CDMRP-SC210277P1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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) 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.

Conditions

Cervical Spinal Cord Injury

Keywords

cervical spinal cord injury; chronic SCI; functional electrical stimulation; electromyography; functional rehabilitation; biomarker

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Aim 1: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2 (Prehension Performance Subtest)

  baseline to 4-week post-intervention follow-up

• Aim 2: Spinal Cord Independence Measure (SCIM)-III

  baseline to 4-week post-intervention follow-up

Other Outcomes (8)

• Expedited International Standards for Neurological Classification of SCI (E-ISNCSCI)

  baseline to 4-week post-intervention follow-up

• Tetraplegia Upper Limb Activities Questionnaire (TUAQ)

  baseline to 4-week post-intervention follow-up

• Demographics/History

  baseline

Study Arms (1)

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.

Device: NeuroLife EMG-FES Sleeve System

Interventions

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.

NeuroLife EMG-FES Sleeve System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead
• United States Department of Defense: collaborator
• Battelle Memorial Institute: collaborator
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (2)

Battelle Memorial Institute

Columbus, Ohio, 43201, United States

RECRUITING

Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion)

Columbus, Ohio, 43210, United States

RECRUITING

Study Officials

• Lauren Wengerd, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• David Friedenberg, PhD

  Battelle Memorial Institute

  PRINCIPAL INVESTIGATOR

• Peyton Miller, OTD

  Ohio State University

  STUDY DIRECTOR

Central Study Contacts

Lauren Wengerd, PhD

CONTACT

330-464-9171; lauren.wengerd@osumc.edu

David Friedenberg, PhD

CONTACT

614-424-5213; friedenbergd@battelle.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 17, 2023
• Study Start: October 31, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-11

Locations

US (2)