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

This study consists of the following three phases: baseline visit, surgical procedure, and
restoration sessions.

At the baseline visit, participants will undergo a medical history review, physical and
neurological examination, functional assessment of motor and sensory capabilities, a
functional magnetic resonance image (fMRI), diffusion tensor image (DTI), and a neuromuscular
stimulation test.

Participants deemed eligible for continued participation will then undergo a craniotomy under
anesthetic sedation to implant the investigational device. The surgeon will implant
microelectrode arrays into the primary motor cortex to record neural activity associated with
desired movements and into the primary somatosensory cortex to deliver stimulation in order
to provide sensory perception.

While in surgical recovery, participants will have their vital signs monitored, be provided
pain medication and antibiotics, and undergo a computed tomography (CT). The participants may
also undergo electromyography and microneurography while in recovery. After being evaluated
by a physician, the participants will be discharged from the hospital to continue their
recovery.

After fully recovering, participants will attend restoration sessions at the Feinstein
Institute for Medical Research's Center for Bioelectronic Medicine. Participants will attend
up to 3 study sessions a week for approximately 12 months, with each session lasting up to 4
hours. The sessions will progressively focus on identifying neural activity related to
desired movements, restoring volitional control of the hand and wrist, restoring tactile
perception, and then restoring volitional control and tactile perception of the hand and
wrist simultaneously.

The study will be considered complete after completion of enrollment (up to 3 participants),
completion of study procedures by all participants, and the completion of analysis of
identifiable study data.

Inclusion Criteria:

1. Males and females between 22 and 65 years of age

2. Individuals with AIS grade A traumatic cervical spinal cord injury with stable motor
level of C5

3. Individuals who cannot sense light touch, pin prick, or pressure in their finger tips
and palm (unilaterally or bilaterally)

4. Individuals at least one year from initial spinal cord injury

5. Individuals that are considered English Proficient due to the study requirements to
follow verbal commands during testing sessions

6. Individuals that are able to comprehend the study goals and procedures, and are able
to provide informed consent for participation.

7. 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.

8. Have the ability and willingness to undergo upper limb electrodiagnostic and nerve
conduction studies

9. 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. Individuals using tobacco or marijuana products

6. Pregnant women

7. Prisoners