NCT06429735招募中不适用
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 15 人开始时间: 2024年1月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Procedure-Related Adverse Events (AE)
研究概览
简要总结
The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. 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
- 22 Years 至 75 Years（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
结局指标
主要结局
Procedure-Related Adverse Events (AE)
时间窗: 12 months post-implant
Device-Related Adverse Events (AE)
时间窗: 12 months post-implant
次要结局
- Procedure-Related Adverse Events (AE)(Up to 72 months post-implant)
- Device-Related Adverse Events (AE)(Up to 72 months post-implant)
研究者
研究点 (2)
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相关资讯
Paralyzed Veteran Becomes First Neuralink Brain-Computer Interface Recipient at University of Miami- A paralyzed U.S. military veteran successfully received Neuralink's brain-computer interface implant at The Miami Project to Cure Paralysis, becoming the fifth participant in the PRIME Study and first at the University of Miami site.
- The patient, known as RJ, can now control computers and smartphones with his thoughts following the April 2025 surgery and was discharged just one day after the procedure.
- The PRIME Study is an investigational clinical trial evaluating the safety and functionality of Neuralink's intracortical brain-computer interface that creates a wireless digital connection between the brain and external devices.
- Neuralink continues recruiting patients with limited hand function due to cervical spinal cord injury or ALS for the ongoing clinical trial.last yearNeuralink Expands Brain-Computer Interface Trial to Canada for ALS and Spinal Cord Injury Patients- Neuralink's CAN-PRIME trial, evaluating its brain-computer interface (BCI), has begun recruiting participants in Canada, marking its first international expansion.
- The trial aims to assess the safety and initial functionality of Neuralink's N1 implant in individuals with quadriplegia due to ALS or spinal cord injury.
- Participants will have the N1 device surgically implanted to enable control of external devices using their thoughts, potentially restoring independence.
- The study involves a six-year monitoring period with regular at-home and in-person clinic visits to evaluate the BCI's performance and long-term effects.last year