Reanimation in Tetraplegia

This study plans to enroll participants who have been diagnosed with C4- C6 ASIA A spinal
cord injuries (motor and sensory complete neurologic injuries), who are more than 1 year post
injury, and who are neurologically stable.

Inclusion Criteria:

- Must be 21 years or older.

- Must be tetraplegic (C4- C6 ASIA A).

- 12 months post injury and neurologically stable.

- Participant is willing to comply with all follow-up evaluations at the specified
times.

- Participant is able to provide informed consent prior to enrollment in the study.

- The participant is fluent in English.

- Participant must have a caregiver willing to participate in the study who will provide
care for the surgical site.

Exclusion Criteria:

- No active wound healing or skin breakdown issues.

- No history of poorly controlled autonomic dysreflexia.

- Medical contraindications for general anesthesia, craniotomy, or surgery.

- Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.

- Participants with any type of destruction and/or damage to the motor cortex region as
determined by MRI.

- History of psychiatric disturbance or dementia

- Other implantable devices such as heart/brain pacemakers

- Participants who rely on ventilators

- Co-morbid conditions that would interfere with study activities or response to
treatment.

- History of a neurological ablation procedure.

- Labeled contraindication for MRI.

- History of hemorrhagic stroke.

- History of HIV infection or ongoing chronic infection (such as tuberculosis).

- Pregnant or of child-bearing potential and are not taking acceptable methods of
contraception.

- Participation in another FDA device or medication trial that would interfere with the
current study.