CompletedNot Applicable

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

United States12 participantsStarted 2023-10-31

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Aim 1: Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) (Object Manipulation Subtest)

Timeframe: baseline to 4-week post-intervention follow-up

Aim 2: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2

Timeframe: baseline to 4-week post-intervention follow-up

Aim 3: Grasp and Release Test (GRT)

Timeframe: baseline to 4-week post-intervention follow-up

Trial details

NCT IDNCT06087445

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-11

View on ClinicalTrials.gov More Cervical Spinal Cord Injury trials

Plain-language summary

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Aim 1: Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) (Object Manipulation Subtest)

Timeframe: baseline to 4-week post-intervention follow-up

Aim 2: Graded and Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP), v2

Timeframe: baseline to 4-week post-intervention follow-up

Aim 3: Grasp and Release Test (GRT)

Timeframe: baseline to 4-week post-intervention follow-up