U.S.-German Collaboration: Optimization of Human Cortical Stimulation
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Link EMG activity produced during a motor task to stimulation of a part of the brain
研究概览
简要总结
We will observe epileptic patients who already have electrodes implanted on the brain and are receiving high-level brain stimulation for clinical purposes while testing their motor and language function. We propose to do a limited, low-level brain stimulation to show that the signatures of local activity in the target area change as an effect of brain stimulation. The goal of this study is to understand the feasibility of a novel recurrent brain-computer interface that could eventually promote targeted functional recovery in subjects who have had a brain injury.
详细描述
The subject will have already been scheduled for placement of the ECoG electrodes on the surface of the brain and who will, for all clinical purposes, subsequently receive stimulation for mapping of function of the ECoG sites. The decision to place the electrodes on the brain, the location of the electrodes and the length of time the electrodes are in are all part of clinical care.
There will be two types of testing, motor and language. Motor will involve inducing stimulation to the thumb cortex and the wrist cortex. There will be a conditioning of this over 4-12 hours. Language will involve showing pictures on a computer screen and the subject will be observed whether speech is disrupted with stimulation or not.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Male and Female
- •Able to understand English for consenting and testing
- •Referred for surgical implantation of electrodes
排除标准
- •Under 18 years of age
- •Pregnant women
- •Prisoners
- •Mentally disabled IQ < 70
- •Non English Speaking
- •Not candidates for surgical implantation of electrodes
结局指标
主要结局
Link EMG activity produced during a motor task to stimulation of a part of the brain
时间窗: 5 years
Attempt to link EMG activity produced during a motor task to stimulation of a part of the brain nearby, but distinct from, the part of the brain normally used to perform the task.
次要结局
- Evaluate distribution of current from stimulation(5 years)
研究者
Jeffrey Ojemann
Professor, Neurological Surgery
University of Washington