Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Marcia Bockbrader
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.
Age
21–89
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
