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

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

Interventions

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.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• Battelle Memorial Institute

  collaborator OTHER

• Congressionally Directed Medical Research Programs

  collaborator FED

• Ohio State University

  lead OTHER

Principal Investigators

• Lauren Wengerd, PhD · Ohio State University

• David Friedenberg, PhD · Battelle Memorial Institute

• Peyton Miller, OTD · Ohio State University

Study Design

Allocation

NA

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-31

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations