Study to Assess the Feasibility of Stimulating the Visual Cortex in Blind Volunteers

Status: Active_not_recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
UCLA Department of Neurosurgery
Los Angeles
Time Frame
Start Date: 2016-08
Completion Date: 2025-12-31
Participants
Target number of participants: 5
Treatments
Experimental: Treatment Group
Subjects will be implanted to assess the feasibility of stimulating visual cortex to restore vision in blind volunteers.
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov

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