Study to Assess the Feasibility of Stimulating the Visual Cortex in Blind Volunteers
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Blindness,Acquired
- 发起方
- University of California, Los Angeles
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Spatial localization of stimulation to produce visual phenomena with direct cortical stimulation.
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
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.
研究者
Ausaf A. Bari, MD, PhD
Principal Investigator
University of California, Los Angeles
入排标准
入选标准
- •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-
- •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.
排除标准
- •Subject is blind due to cortical etiology (e.g. injury to the visual cortex).
- •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,
- •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
- •Subject has a prior history of seizures or epilepsy.
- •Subject has Parkinson's disease
结局指标
主要结局
Spatial localization of stimulation to produce visual phenomena with direct cortical stimulation.
时间窗: 6 months
Anatomic outcome. No predetermined outcome scale exists. We will assess patients and the sites of brain stimulation to determine which areas of the brain produce reliable visual phenomena when stimulated.
Characterization of stimulation-induced visions
时间窗: 6 months
Descriptive outcome. Subjects will be asked to describe the type of visual perception that is induced by direct brain stimulation.
Stimulation level required to elicit visual phosphene
时间窗: 6 months
Quantitative outcome. Direct brain stimulation to reproduce visual phenomena has not been done. There are no predesigned outcome measures. For this outcome measure, we will determine how much stimulation (in amps) is required to induce a perception of vision.