Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System

Eligibility 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 12 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
• 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