NCT07127172招募中不适用
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Neuralink Corp2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2025年7月31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
- 7
- 试验地点
- 2
- 主要终点
- The Rate of Device-Related Adverse Events (AE)
研究概览
简要总结
The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions.
The N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •(a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.
- •OR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.
- •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
GB-PRIME: Precise Robotically Implanted Brain-Computer Interface
Other
Open label
干预措施: N1 Implant (Device)
GB-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 Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study(From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation)
- The Rate of Device-Related Adverse Events (AE)(Up to 48 months post-implant)
- The Rate of Procedure-Related Adverse Events (AE)(Up to 48 months post-implant)
- Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase(From baseline to 48-months post-implantation)
- Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase(From baseline to 48-months post-implantation)
- 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 1-, 3-, 6-, 9-, and 12-months post-implantation)
- Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase(From baseline to 48-months post-implantation)
研究者
研究点 (2)
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