A Study of Direct Brain Recording and Stimulation for Memory Enhancement
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- to identify biomarkers of successful memory encoding and retrieval
研究概览
简要总结
Background:
- Epilepsy is a seizure disorder. Sometimes it is treated with surgery. During surgery, electrodes are placed on or in the brain. Researchers want to learn more about memory and the brain. They want to do tests on people who are having epilepsy surgery.
Objective:
- To learn more about memory and brain function by recording brain cell activity during memory tasks.
Eligibility:
- Adults age 18 - 65 who have medically intractable epilepsy and will have electrodes placed to identify the source of their seizures. They must be currently enrolled in protocol 11-N-0051.
Design:
- Participants may do memory tests before the electrodes are put in, while they are in place, and after surgery. Researchers may stimulate areas of the brain with small pulses of electricity.
- Researchers will start recording brain activity at least 12 hours after electrodes are placed. They will record while participants are awake and asleep. They will record before, during, and after seizures.
- Participants may have up to 3 testing sessions daily over the 1-3 weeks the electrodes are in place. Each session will last 20-60 minutes.
- Participants will play games on a laptop. Sometimes they may use a button or joystick. This can be done in bed in the hospital.
- Participants may be given a list of words and asked to recall them in a short time.
- Participants may be given pairs of items and asked to remember how they are related.
- Participants may be asked to learn their way around a virtual town on the computer. Their eye movements may be tracked by a small camera.
详细描述
Objective
The primary objectives of this study are (1) to identify biomarkers of successful memory encoding and retrieval, and (2) to identify brain regions that can be stimulated to affect memory performance. The secondary objective is to identify biomarkers that can be used to predict cognitive impairment following resection surgery.
Study Population
One hundred (100) adult subjects with epilepsy who are enrolled in 11-N-0051 Epilepsy Surgery protocol.
Study Design
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •To be eligible for entry into the study, candidates must meet all the following criteria:
- •Be enrolled in 11-N-0051 Epilepsy Surgery.
- •Able to give informed consent.
- •Age greater than or equal to 18 years and less than or equal to 65 years
排除标准
- •Candidates will be excluded if they:
- •Have any disability that would limit their ability to perform study tasks that examine memory function.
研究组 & 干预措施
Patients
Patients age >18 years and <= 65 years enrolled in 11-N-0051 Epilepsy Surgery
结局指标
主要结局
to identify biomarkers of successful memory encoding and retrieval
时间窗: during visits/hospitalizations for 11-N-0051
We will compare brain recordings during memory encoding for items that are later recalled versus items that are not later recalled. For example, broadband oscillatory activity from electrodes in human temporal lobe has been shown to predict which items are later recalled
to identify brain regions that can be stimulated to enhance memory performance
时间窗: during visits/hospitalizations for 11-N-0051
We will correlate task performance across a variety of memory tasks and electrode locations with stimulation parameters (e.g. frequency and amplitude), to identify those brain areas and stimulation parameters that increase task performance.
次要结局
- to identify biomarkers that can be used to predict cognitive impairment following resection surgery(Ongoing)