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

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