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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: Recruiting NA study of Cervical Spinal Cord Injury, sponsored by Ohio State University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluation of object manipulation while simulating 10 ADL tasks.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-10-31 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What NCT06087445 shows while recruiting
NCT06087445 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 21-participant average among 18 other Cervical Spinal Cord Injury trials with a reported enrollment target (43% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06087445's enrollment target sits among peer trials
12 10th of 18 higher than 7 of 18 other Cervical Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Spinal Cord Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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