Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02) (BG-Aphasia-02)
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia
In this study, the investigators aim to continue the development of a brain-computer interface (BCI) to help restore speech for stroke survivors with agrammatic aphasia, a language disorder that affects the ability to speak.
研究概览
详细说明
One in four adults will have a stroke in their lifetime. When the blood flow to the brain is blocked or reduced, brain cells get deprived of oxygen. This might impact language areas in the brain and lead to aphasia.
The goal of this project is to advance the methods by which people with aphasia can help develop and by using an intracortical brain-computer interface (iBCI) restore communication that may serve as a rehabilitation device.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Leigh R Hochberg, M.D., Ph.D.
- 电话号码：617-724-9247
- 邮箱：lhochberg@mgh.harvard.edu
学习地点
-
-
California
-
Sacramento、California、美国、95817
- University of California, Davis
-
接触：
- David M Brandman, M.D., Ph.D.
- 邮箱：dmbrandman@health.ucdavis.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Inclusion Criteria:
- Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis, or other motor neuron disorders
- Complete or incomplete tetraplegia (quadriplegia)
- Prior enrollment in BrainGate2 clinical trial (NCT00912041)
Exclusion Criteria:
- Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
- Chronic oral or intravenous steroids or immunosuppressive therapy
- Other serious disease or disorder that could seriously affect ability to participate in the study
(There are additional exclusion criteria)
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：BrainGate Neural Interface System
Device: BrainGate Neural Interface System |
Placement of the BrainGate2 sensor(s) for restoration of speech |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sensor implant duration for at least one-year without any device-related Serious Adverse Events or explant
大体时间：1 year
|
To determine the safety of the Sensor and overall safety of the System. Participants will be considered a success for this safety measure if they are successfully implanted with the Sensor(s) and:
|
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.