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NCT06087445
A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia
NA trial testing NeuroLife EMG-FES Sleeve System in Cervical Spinal Cord Injury in 12 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Ohio State University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 12 |
| Start date | 31 October 2023 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- NeuroLife EMG-FES Sleeve System
Conditions studied
- Cervical Spinal Cord Injury — all drugs for Cervical Spinal Cord Injury →
Sponsor
Ohio State University
Who can join
22 and older, any sex, with Cervical Spinal Cord Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710
Verify or expand the search:
- PubMed search for NCT06087445
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cervical Spinal Cord Injury
Currently open trials in the same condition.
- NCT06701422 — Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery · NA · recruiting
- NCT06700304 — CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices · NA · recruiting
- NCT06225245 — Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord · NA · recruiting
- NCT06511934 — Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01) · NA · recruiting
- NCT06440538 — Rebuilding Inter-limb Transfer in Cervical SCI · EARLY_PHASE1 · active not recruiting
Other Ohio State University trials
Trials by the same sponsor.
- NCT06542458 — Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog · not yet recruiting
- NCT07217548 — Solving Stigma Through POV Simulation: Enhancing Pharmacist Empathy-based Practices With Sickle Cell Disease Patients · NA · enrolling by invitation
- NCT07215221 — Implementation of TBI-RECOVER in Substance Use Treatment · NA · not yet recruiting
- NCT07278427 — Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START · recruiting
- NCT07490444 — Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06087445 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ohio State University
- Last refreshed: 24 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06087445.
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