Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System (NCT03680872)
🩺 Plain-English Summary (8th-Grade Level)
This is a single-cohort early feasibility trial to determine whether an investigational device called the Bidirectional Neural Bypass System can lead to the restoration of movement and sensation in the hand and wrist of up to seven individuals with tetraplegia.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (33 items).
Location: Northwell Health's The Feinstein Institute for Medical Research — Manhasset, New York
Age range: 22 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Individuals participating in another research study that may affect the conduct or results of this study
- Individuals having or exhibiting any of the following:
- Medical contraindications for diffusion tensor imaging, functional magnetic resonance imaging, electromyography, computed tomography, cortical stimulation, or craniotomies/surgeries
- Prior difficulties or allergy to general anesthesia
- Active wound healing or skin breakdown issues
- Stage III-IV pressure ulcers
- Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other)
- Prior tendon transfer to enhance hand function
- History of autoimmune disease
- Cancer
- Biochemical abnormalities of the liver, kidney, or pancreas
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Northwell Health's The Feinstein Institute for Medical Research — Manhasset, New York
📞 Contact the Study Coordinator
Phone: (516) 562-3634
Email: eibroci@northwell.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.