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NCT06087445 · ClinicalTrials.gov registry record · NA

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

A NA study of Cervical Spinal Cord Injury, sponsored by Ohio State University.

Recruiting
Registry status
NA
Development phase
12
Enrollment target
2
Study locations

NCT06087445 is a NA study of Cervical Spinal Cord Injury that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 12 participants, below the 21-participant average among 18 other Cervical Spinal Cord Injury trials with a reported enrollment target (43% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT06087445, a NA study of Cervical Spinal Cord Injury, is actively recruiting participants, sponsored by Ohio State University.

RECRUITING
Registry status
NA
Development phase
12 participants
Enrollment target
2
Study locations

Study 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 Studied

Cervical Spinal Cord Injury

Interventions

  • DEVICE NeuroLife EMG-FES Sleeve System

Study Locations (2)

Ohio

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

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2023-10-31
Est. Completion 2026-08-31
Phase NA

Sponsor

Ohio State University

552 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06087445

The ClinicalTrials.gov registry entry for NCT06087445 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 21-participant average among 18 other Cervical Spinal Cord Injury trials with a reported enrollment target (43% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cervical Spinal Cord Injury appearing as the primary indexed condition, and to 1 intervention - of which NeuroLife EMG-FES Sleeve System is the first listed.

NCT06087445 reports 2 study locations spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT06087445 about?

NCT06087445 is a clinical study titled "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-invas...

What is the current status of trial NCT06087445?

This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2023-10-31. Estimated completion is 2026-08-31.

What conditions does trial NCT06087445 study?

This clinical trial studies the following conditions: Cervical Spinal Cord Injury.

What interventions are being tested in trial NCT06087445?

The interventions under investigation include: NeuroLife EMG-FES Sleeve System (DEVICE).

Who is sponsoring clinical trial NCT06087445?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06087445 being conducted?

This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.