Early Feasibility Study of the Orion Visual Cortical Prosthesis System

Exclusion Criteria

• •1. Subject is at high risk for surgical complications such as active systemic infection, coagulation disorders (such as the use of anti-thrombotic therapies) or platelet count below 100,000.
• •2. Subject has history of bleeding or immune compromise.
• •3. Subject is taking chronic anticoagulants or antiplatelet agent or subject has an abnormally elevated preoperative coagulation profile (either PTT or PT/INR).
• •4. Subject has had prior craniotomy or brain surgery that would interfere with placement or function of Orion device.
• •5. Subject has evidence of active intracranial disease that would preclude elective neurosurgical intervention, such as unruptured intracranial aneurysm or brain tumor, or aberrant visual cortex anatomy, such as prior stroke or arteriovenous malformation.
• •6. Subject has a significant abnormality on preoperative brain MRI.
• •7. Subject has a prior history of seizures or epilepsy.
• •8. Subject has Parkinson's disease.
• •9. Subject has a prior history of serious head injury with loss of consciousness for more than 24 hours.
• •10. Subject has a progressive central nervous system disease.
• •11. Subject has a history of implant-related infection.
• •12. Subject requires or is likely to require any of the following medical procedures while implanted with the Orion System: MR imaging, diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS). These medical procedures are contraindicated for subjects implanted with an Orion System. Energy from these procedures can be sent through the implanted brain stimulation system and cause permanent brain damage which may cause severe injury, coma, or death.
• •13. Subject is implanted with any neurostimulation or neuromodulation device in the head including, but not limited to cochlear implant, deep brain stimulator, or auditory brain implant.
• •14. Subject has a clinically significant or unstable medical condition including uncontrolled systemic hypertension with values above 170/100; cardiac or pulmonary disease; uncorrected coagulation abnormalities; diabetes; or any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician.
• •15. Subject has had an alcohol or illicit substance use disorder within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response.
• •16. Subject has uncontrolled chronic pain.
• •17. Subject has significant neurocognitive impairment in memory domain (based on MoCA-BLIND \<18 or WAIS-IV \<80, described below).
• •18. Subject had moderate or severe depression, as determined by a score of at least 17 on the HAM-D.
• •19. Subject has had a suicide attempt in the last two years, presence of a suicide plan (an answer of "Yes" to Question C4 in Section C-Suicidality of MINI International Neuropsychiatric Interview), or a "yes" answer to any one of the ten suicidal ideation and behavior questions on the C-SSRS.
• •20. Subject has a disease or condition that prevents understanding or communication of informed consent, study demands, or testing protocols, including:
• •1. Cognitive decline including diagnosed forms of dementia and/or progressive neurologic disease
• •2. Psychiatric disease including diagnosed forms of depression
• •3. Does not speak a principal language associated with the region
• •4. Deafness or selective frequency hearing loss that prevents adequate communication with the researchers.
• •21. Subject has a balance disability or frequently participates in contact sports.
• •22. Subject must administer diathermy as part of his/her livelihood.
• •23. Subject is pregnant or is planning on becoming pregnant in the next year.
• •24. Subject has unrealistic expectations of the benefits of the study.
• •25. Subject is enrolled in another therapeutic investigational drug or device trial