NCT06700304招募中不适用
CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Neuralink Corp1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年11月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The Rate of Device-Related Adverse Events (AE)
研究概览
简要总结
The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
- •Life expectancy ≥ 12 months.
- •Ability to communicate in English
- •Presence of a stable caregiver
排除标准
- •Moderate to high risk for serious perioperative adverse events
- •Active implanted devices
- •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
- •Use of smoking tobacco or other tobacco products
- •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
研究组 & 干预措施
CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface
Other
Open label
干预措施: N1 Implant (Device)
CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface
Other
Open label
干预措施: R1 Robot (Device)
结局指标
主要结局
The Rate of Device-Related Adverse Events (AE)
时间窗: 12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
时间窗: 12 months post-implant
次要结局
- Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study(From baseline to 3-, 6-, 9-, and 12-months post-implantation)
- Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study(From baseline to 3-, 6-, 9-, and 12-months post-implantation)
- Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase(From baseline to 36-months post-implantation)
- The Rate of Procedure-Related Adverse Events (AE)(Up to 36 months post-implant)
- Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase(From baseline to 36-months post-implantation)
- Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study(From baseline to 3-, 6-, 9-, and 12-months post-implantation)
- Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase(From baseline to 36-months post-implantation)
- The Rate of Device-Related Adverse Events (AE)(Up to 36 months post-implant)
研究者
研究点 (1)
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