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.