Clinical trial NCT03344848: Early Feasibility Study of the Orion Visual Cortical Prosthesis System
Official title: Early Feasibility Study of the Orion Visual Cortical Prosthesis System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Blindness, Acquired
Lead sponsor: Second Sight Medical Products
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2017-11-17
Enrollment: 6
Sex: ALL
Minimum age (years): 22
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is an early feasibility study of a new device, the Orion Visual Cortical Prosthesis System. The device is intended to stimulate the surface of the visual cortex to induce visual perception in blind individuals.

Detailed description: In this study, 6 subjects with bare light or no light perception in both eyes will be implanted with the Orion Cortical Visual Prosthesis System. The study will evaluate the safety of the device and surgery, as well as reliability of the system and the usefulness of any restored vision. Each subject will be followed for 6 years, with their health monitored throughout. Research sessions, visual function testing, and subject-reported outcomes will be used to evaluate the functioning of the system.

Eligibility criteria: Inclusion Criteria:

1. Subject is bilaterally blind with bare or no light perception. This is defined as non-measurable binocular visual acuity or 5° or less visual field in each eye.
2. Subject is bilaterally blind due to:

   1. Trauma to the eye, or
   2. Disease or damage of the retina (such as retinopathy, retinal vein occlusion, inherited retinal diseases or retinal detachment), or
   3. Disease or damage of the optic nerve or chiasm (such as glaucoma, methanol intoxication, autoimmune neuropathies, pituitary pathology, and hereditary neuropathies)
3. Subject's vision cannot be restored with any approved medication or intervention.
4. Subject has a documented history of useful form vision.
5. Subject is between the age of 22-74 .
6. Subject resides within 2 hours (by ground transportation) of the investigational site.
7. 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 (c) a female who is at least two years post-menopause or otherwise unable to bear children.
8. Subject is able to complete regular office and telephone appointments per the protocol requirements.
9. Subject is medically fit for neurosurgical intervention.

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

Primary outcomes:
measure: Rate of Device- or Procedure-Related Adverse Events (Safety)
timeFrame: Through study completion, an average of 6 years
Secondary outcomes:
measure: Ability to Create Visual Perception as Measured by Stimulation Thresholds
timeFrame: 1 month, 6 months, 12 months, 24 months, 60 months, 72 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Second Sight Medical Products
name: Uday Patel, PhD
role: STUDY_DIRECTOR
References:
citation: Beauchamp MS, Oswalt D, Sun P, Foster BL, Magnotti JF, Niketeghad S, Pouratian N, Bosking WH, Yoshor D. Dynamic Stimulation of Visual Cortex Produces Form Vision in Sighted and Blind Humans. Cell. 2020 May 14;181(4):774-783.e5. doi: 10.1016/j.cell.2020.04.033.