NCT06710626Enrolling By Invitation不适用
CONVOY: An Early Feasibility Study of Neural Control of Assistive Devices Via Brain-Computer Interface Technology
Neuralink Corp2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2024年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant.
研究概览
简要总结
The CONVOY Study is a clinical trial designed to explore the feasibility of participants from the PRIME Study (NCT06429735) using the N1 Implant to control various assistive devices. The main goal is to determine whether participants can successfully modulate their brain activity to control devices, such as an Assistive Robotic Arm (ARA). This study will assess the effectiveness, consistency, and safety of neural control using the ARA and other assistive devices.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Continued enrollment in the PRIME Study.
- •Implanted with the N1 Implant.
排除标准
- •Explantation or deactivation of the N1 Implant.
- •Insufficient N1 Implant BCI performance demonstrated.
- •Lack of a suitable physical space to perform research sessions.
- •Any condition which, in the opinion of the Investigator, would compromise the candidate's ability to safely participate in the study.
结局指标
主要结局
Ability of participants to modulate brain activity for controlling an assistive device via the N1 Implant.
时间窗: 3-months following first use of the assistive device
次要结局
- Rate of Device-Related Adverse Events (AE)(Up to 72 months after enrollment)
- Assessment of Quality of Life Using the Psychosocial Impact of Assistive Devices Scale (PIADS)(From enrollment, every 3 months, up to 72 months)
- Change in Assistive Technology Device Predisposition Assessment (ATD PA) Score(From enrollment, every 3 months, up to 72 months)
研究者
研究点 (2)
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