Feasibility of Stimulating the Visual Cortex in Blind (NCT02747589) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Feasibility of Stimulating the Visual Cortex in Blind
United States5 participantsStarted 2016-08
Plain-language summary
In this study, the investigators intend to evaluate the use of a commercially available neurostimulator system, NeuroPace RNS System to stimulate the visual cortex. The NeuroPace RNS System has a proven record of safety and reliability was approved by the FDA in November 2013. The RNS System is indicated for use in patients with epilepsy and includes a skull implanted neurostimulator. No modification to the RNS System is required for this study. This study will use this device to better understand the effect of stimulation on the visual parts of the brain.
The main purposes of this study are to confirm the desired location to implant a device in the visual cortex, determine the amount of energy needed to elicit vision, and assess the nature of the vision that is produced. This information is important to have early in the process of designing a visual cortical prosthesis that could eventually be used for commercial use.
Who can participate
Age range18 Years – 74 Years
SexALL
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Inclusion criteria
✓. Subject is blind (i.e. bare light perception or no light perception in both eyes).
✓. Subject has a history of useful form vision.
✓. Subject is between the age of 18-74.
✓. Subject resides within 2 hours distance (by ground transportation) of the investigational site.
✓. 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.
✓. Subject is able to complete regular office and telephone appointments per the protocol requirements.
✓. Subject is medically fit for neurosurgical intervention.
✓. Subject is considered a good candidate to be implanted with the investigational device.
Exclusion criteria
✕. Subject is blind due to cortical etiology (e.g. injury to the visual cortex).
What they're measuring
1
Stimulation level required to elicit visual phosphene
Timeframe: 6 months
2
Characterization of stimulation-induced visions
Timeframe: 6 months
3
Spatial localization of stimulation to produce visual phenomena with direct cortical stimulation.
✕. Subject is eligible for another commercially available vision restoration therapy (e.g. retinal prosthesis).
✕. 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.
✕. Subject has history of bleeding or immune compromise.
✕. Subject is taking chronic anticoagulants or antiplatelet agent or subject has an abnormally elevated preoperative coagulation profile (either PTT or PT/INR).
✕. Subject has had prior craniotomy or brain surgery.
✕. 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.
✕. Subject has a significant abnormality on preoperative brain MRI