| Eligibility |
Inclusion Criteria:
1. Subject is blind (i.e. bare light perception or no light perception in both eyes).
2. Subject has a history of useful form vision.
3. Subject is between the age of 18-74.
4. Subject resides within 2 hours distance (by ground transportation) of the
investigational site.
5. Subject is (a) male or (b) a female of childbearing potential with a negative
pregnancy test who is using a reliable method of contraception or is at least two
years post-menopause.
6. Subject is able to complete regular office and telephone appointments per the protocol
requirements.
7. Subject is medically fit for neurosurgical intervention.
8. Subject is considered a good candidate to be implanted with the investigational
device.
Exclusion Criteria:
1. Subject is blind due to cortical etiology (e.g. injury to the visual cortex).
2. Subject is eligible for another commercially available vision restoration therapy
(e.g. retinal prosthesis).
3. 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.
4. Subject has history of bleeding or immune compromise.
5. Subject is taking chronic anticoagulants or antiplatelet agent or subject has an
abnormally elevated preoperative coagulation profile (either PTT or PT/INR).
6. Subject has had prior craniotomy or brain surgery.
7. 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.
8. Subject has a significant abnormality on preoperative brain MRI
9. Subject has a prior history of seizures or epilepsy.
10. Subject has Parkinson's disease
11. Subject has a prior history of serious head injury with loss of consciousness.
12. Subject has a progressive central nervous system disease.
13. Subject has history of implant-related infection.
14. Implantation of the investigational device would present unacceptable risk.
15. Subject requires or is likely to require any of the following medical procedures while
implanted with the NeuroPace RNS System: MR imaging, diathermy, electroconvulsive
therapy (ECT), or transcranial magnetic stimulation (TMS). These medical procedures
are contraindicated for patients with an implanted RNS® 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. Brain damage can
occur from any of the listed procedures even if the RNS® Neurostimulator is turned off
or if the Leads are not connected to the Neurostimulator, and can occur even if the
Neurostimulator has been removed and any Leads (or any part of a Lead) or the cranial
prosthesis remain. Refer to the Contraindications section of the RNS System User
Manual for further details.
16. 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.
17. 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.
18. 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.
19. Subject has uncontrolled chronic pain.
20. Subject has significant neurocognitive impairment in memory domain (based on
MoCA-BLIND <18 or WAIS-IV <80, described below).
21. Subject had moderate or severe depression, as determined by a score of at least 17 on
the HAMD.
22. 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.
23. Subject has a disease or condition that prevents understanding or communication of
informed consent, study demands, and 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.
24. Subject is pregnant or planning on becoming pregnant in the next year.
25. Subject is enrolled in another therapeutic investigational drug or device trial
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