Restoring hand and wrist function in people with tetraplegia using a neural device
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
This study is testing a new device to see if it can help people with tetraplegia regain movement and feeling in their hands and wrists.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Manhasset, New York) |
| Trial ID | NCT03680872 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of the Bidirectional Neural Bypass System in restoring movement and sensation in the hands and wrists of individuals with tetraplegia. Participants will undergo a series of assessments, including medical history reviews and imaging tests, followed by a surgical procedure to implant microelectrode arrays in the brain. After recovery, they will attend multiple restoration sessions over the course of a year to assess the device's impact on their motor and sensory capabilities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 to 65 with stable cervical spinal cord injuries and limited motor and sensory function in their hands.
Not a fit: Patients with non-stable spinal cord injuries or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hand and wrist function in individuals with tetraplegia, enhancing their quality of life.
How similar studies have performed: While this approach is innovative, similar studies exploring neural interfaces have shown promise in restoring function in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females between 22 and 65 years of age 2. Individuals with a stable cervical spinal cord injury that have International Standards for the Neurological Classification of SCI (ISNCSCI) motor scores for fingers of 0 - 2 (non-functional) and ISNCSCI sensory scores of 0 - 2 (not normal) on the palmar side 3. Individuals at least one year from initial spinal cord injury 4. Individuals that are considered English Proficient due to the study requirements to follow verbal commands during testing sessions 5. Individuals that are able to comprehend the study goals and procedures, and are able to provide informed consent for participation. 6. Individuals that are willing and able to visit the study center for study procedures that will be 1-3 sessions a week for up to 48 months at 1-4 hours per session. 7. Have the ability and willingness to undergo upper limb electrodiagnostic and nerve conduction studies 8. Demonstrate typical amplitude, latency, and conduction velocity in the distal median, ulnar, and radial nerves of at least one upper limb Exclusion Criteria: 1. Individuals participating in another research study that may affect the conduct or results of this study 2. Individuals having or exhibiting any of the following: 1. Medical contraindications for diffusion tensor imaging, functional magnetic resonance imaging, electromyography, computed tomography, cortical stimulation, or craniotomies/surgeries 2. Prior difficulties or allergy to general anesthesia 3. Active wound healing or skin breakdown issues 4. Stage III-IV pressure ulcers 5. Chronically-implanted electronic medical device (e.g. baclofen pump, deep brain stimulator, epidural stimulator, cardiac pacemaker, vagus nerve stimulator, or other) 6. Prior tendon transfer to enhance hand function 7. History of autoimmune disease 8. Cancer 9. Biochemical abnormalities of the liver, kidney, or pancreas 10. Ventilator dependence 11. History of serious mood or thought disorder 12. Significant residual clinically evident traumatic brain injury or cognitive impairment 13. Uncontrolled autonomic dysreflexia 14. Spasticity in the upper extremities that is uncontrolled by pharmacological methods 15. Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months 16. Individuals with any type of destruction and/or damage to the motor cortex region as determined by fMRI. 17. History of a neurological ablation procedure 18. History of hemorrhagic stroke 19. History of infectious or chronic diseases, such as HIV or tuberculosis 3. Individuals with any of the following co-morbid conditions that would interfere with study activities or response to treatment: 1. Life expectancy \< 3 years 2. Severe chronic pulmonary disease 3. Intractable seizure disorders 4. Local, systemic acute or chronic infectious illness 5. Life threatening cardiac arrhythmias 6. Severe collagen vascular disorder 7. Kidney failure or other major organ systems failures 4. Individuals with a substance abuse (alcoholism or other) problem 5. Pregnant women 6. Prisoners
Where this trial is running
Manhasset, New York
- Northwell Health's The Feinstein Institute for Medical Research — Manhasset, New York, United States (Recruiting)
Study contacts
- Principal investigator: Chad E Bouton, MS — Northwell Health
- Study coordinator: Erona Ibroci, MPH
- Email: eibroci@northwell.edu
- Phone: 516-562-3634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.