Cortical Recording and Stimulating Array Brain-Machine Interface

Inclusion Criteria:

1. Subjects must have limited or no ability to use one or both hands due to cervicalspinal cord injury, brainstem stroke, brachial plexus injury, above-elbowamputation, or spinal stroke. Individuals with intact limbs must have less thangrade 2 strength in finger flexor and abduction on the contralateral side to theimplant and a t-score <35 on the PROMIS Upper Extremity Short Form. Thenon-functional hand(s) may be involved passively in functional tasks; for example,pushing an object or passively grasping an object placed into the hand. However, theparticipant must report that they have no functional use of their hand(s).

2. Subjects must report that they are unable to perform functional activities with thehand contralateral to implantation.

3. Subjects must be over 1 year post-injury at time of implantation. In addition,subject must report no worsening in neurologic status (strength, sensation) for theprevious 6 months.

4. Subjects must be between the ages of 22-70 years old at the time of enrollment andcompletion of the study. Participants outside this age range may be at an increasedsurgical risk and increased risk of fatigue during BMI training.

5. Subjects must live within 2 hours of the research site during the study or bewilling to travel to the research site at least once per week for BMI training.

6. If subjects do not live in the area, they are expected to stay somewhere within 2hours of the research site for at least 18 months after enrollment.

7. Subjects must be able to communicate with the investigators in English because ofthe need to follow the instructions of the study team.

8. Subjects must show an understanding of the study goals and have the ability tofollow simple directions as judged by the investigators

9. Subjects must have results that are within normal limits on neuropsychological andpsychosocial assessment; psychosocial health and support will be assessed byinterview with the psychologist.

10. Subjects must be able to activate distinct cortical areas during imagined orattempted movement tasks (i.e. hand movement and speaking or moving the mouth); thiswill be evaluated with functional magnetic resonance imaging (fMRI) as part ofscreening.

11. Subjects must have a stable psychosocial support and caregivers who are able toperform the necessary daily care of the participant's skin and pedestal site. Thisrequires that the subject identify a caregiver and a backup who have been in placefor greater than 6 months and are able to provide needed physical and psychosocialsupport. This will be assessed by the sponsor-investigator and study neurosurgeon.

12. Subjects must have a life expectancy greater than 18 months as assessed by the studyinvestigator and neurosurgeon sub-investigator

13. Documentation of informed consent must be obtained from the participant or theirlegal representative.

14. Participants with transhumeral amputation must have been evaluated for a prosthesis,and if deemed appropriate, were fit with an optimized prosthesis. The prosthesisshould be used/considered for the PROMIS evaluation.

Exclusion Criteria:

1. Visual impairment such that extended viewing of a computer monitor would bedifficult even with ordinary corrective lenses

2. Another serious disease(s) or disorder(s) that could affect ability to participatein this study (verified during pre-op anesthesia evaluation to determine surgicalrisk status)

3. Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest

4. Metallic implant(s) that would prohibit the subject from having an fMRI scan; spinalfixators are generally non-ferrous and would not exclude someone from participatingin the study

5. Any type of implantable generator such as a pacemaker, spinal cord stimulator,cochlear implant, deep brain stimulator (DBS), DBS leads, vagus nerve stimulator, ordefibrillator

6. Women of childbearing age who are pregnant, lactating, or plan to become pregnantduring the next 25 months

7. Allergy to contrast medium or kidney failure that could be exacerbated by contrastagent (for MRI)

8. Subjects receiving medications (such as sedatives) chronically that may retard motorcoordination and cognitive ability

9. Individuals who require routine MRI, therapeutic ultrasound, or diathermy

10. Individuals with osteomyelitis

11. Severe skin disorder that causes excessive skin sloughing, lesions or breakdown ofthe scalp

12. History of myocardial infarction or cardiac arrest or with intractable cardiacarrhythmias

13. Individuals with an implanted hydrocephalus shunt

14. Individuals who have had a stroke caused by a surgical procedure

15. Active infection(s) or unexplained fever (verified during pre-op anesthesiaevaluation to determine surgical risk status)

16. Consumption of more than 1 alcoholic beverage per day on average

17. Receiving chronic oral or intravenous steroids or immunosuppressive therapy

18. Active cancer within the past year (other than adequately treated basal cell orsquamous cell skin cancer) or require chemotherapy

19. Uncontrolled insulin dependent diabetes mellitus

20. Uncontrolled autonomic dysreflexia within the past 3 months (for those with spinalcord injury)

21. Individuals with seizure disorders currently being treated with anti-epilepticmedications and individuals with a familial history of seizure disorders

22. Individuals who have attempted suicide in the past 12 months

23. Individuals who are immunosuppressed or who have conditions that typically result inimmunocompromise (including, but not limited to: ataxia-telangiectasia, cancer,Chediak-Higashi syndrome, combined immunodeficiency disease, complementdeficiencies, DiGeorge syndrome, HIV/AIDS, hypogammaglobulinemia, Job syndrome,leukocyte adhesion defects, malnutrition, panhypogammaglobulinemia, Bruton disease,congenital agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrichsyndrome)

24. Individuals who have had previous neurosurgical intervention involving the frontallobes (especially the motor cortex) and/or parietal lobe (especially thesomatosensory cortex) that is likely to impact the viability of an intracorticalelectrode

25. Individuals with active psychiatric concerns, including but not limited to majordepression, bipolar disorder, schizophrenia or other psychotic disorder andpost-traumatic stress disorder

26. Individuals with substance abuse within 6 months of study participation

27. Individuals who are judged by a clinician as being an unsafe ambulator - This wouldbe decided based on a history of frequent uncontrolled falls more than 3 or 4 in ayear, or falls that resulted in injury

28. Individuals who plan to participate in contact sports or sports that require ahelmet