VOICE：用于沟通恢复的精确机器人植入脑机接口早期可行性研究
VOICE：用于通信恢复的精确机器人植入脑机接口早期可行性研究
The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
研究概览
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：Neuralink Clinical Team
- 电话号码：+1 (650) 250-0520
- 邮箱：voice-study@neuralink.com
学习地点
-
-
Texas
-
Dallas、Texas、美国、75390
- 招聘中
- The University of Texas Southwestern Medical Center
-
接触：
- Nader Pouratian, MD
- 电话号码：214-645-1355
- 邮箱：voice-study@neuralink.com
-
首席研究员：
- Nader Pouratian, MD
-
-
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:
Adults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.
- Life expectancy ≥ 12 months.
- Ability to communicate in English
- Presence of a stable caregiver
Exclusion Criteria
- Moderate to high risk for serious perioperative adverse events
- Morbid obesity (Body Mass Index > 40)
- History of poorly controlled seizures or epilepsy
- History of poorly controlled diabetes
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
- Acquired or hereditary immunosuppression
- Psychiatric or psychological disorder
- Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
- Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 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：Neuralink N1 Implant and R1 Robot
Implantation of the N1 Implant by the R1 Robot. |
The N1 Implant is a type of implantable brain-computer interface
其他名称：
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
其他名称：
|
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 |
|---|---|---|
|
Device-Related Adverse Events (AE)
大体时间：12 months post-implant
|
The proportion of subjects with device-related adverse events (AEs) at the 12-month follow-up visit. |
12 months post-implant
|
|
Procedure-Related Adverse Events (AE)
大体时间：12 months post-implant
|
The proportion of subjects with procedure-related adverse events (AEs) at the 12-month follow-up visit. |
12 months post-implant
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Long-term Device-Related Adverse Events (AE)
大体时间：Up to 48 months post-implant
|
The proportion of subjects with device-related adverse events (AEs) up to the 48-month long-term follow-up visit. |
Up to 48 months post-implant
|
|
Long-term Procedure-Related Adverse Events (AE)
大体时间：Up to 48 months post-implant
|
The proportion of subjects with procedure-related adverse events (AEs) up to the 48-month follow-up visit. |
Up to 48 months post-implant
|
|
Preliminary efficacy of the R1 Robot
大体时间：During surgical implantation procedure
|
Preliminary efficacy of the R1 Robot will be evaluated by measuring the following percent of electrodes inserted (reported as electrodes inserted / total electrodes). |
During surgical implantation procedure
|
|
Preliminary efficacy of the N1 Implant
大体时间：Up to 48 months post-implant
|
Preliminary efficacy of the N1 Implant will be evaluated by measuring the following BCI performance for speech, quantified by measuring the monthly maximum correct word per minute (CWPM). |
Up to 48 months post-implant
|
合作者和调查者
调查人员
- 首席研究员：Nader Pouratian, MD、University of Texas Southwestern Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
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
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- N1-EFS-200
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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