临床试验/NCT06429735

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2024年1月9日

适应症Tetraplegia/Tetraparesis Quadriplegia Cervical Spinal Cord Injury Amyotrophic Lateral Sclerosis Quadriplegia/Tetraplegia Tetraplegic; Paralysis

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Tetraplegia/Tetraparesis
发起方: Neuralink Corp
入组人数: 15
试验地点: 2
主要终点: Procedure-Related Adverse Events (AE)
状态: 招募中
最后更新: 3个月前

概览研究者入排标准结局指标研究点相似试验相关资讯

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.

注册库

clinicaltrials.gov

开始日期

2024年1月9日

结束日期

2031年1月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Neuralink Corp

责任方

Sponsor

入排标准

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.

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)

研究点 (2)

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CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External DevicesTetraplegia/TetraparesisQuadriplegiaQuadriplegia/TetraplegiaCervical Spinal Cord InjuryAmyotrophic Lateral Sclerosis (ALS)Spinal Cord Injury (Quadraplegia)Spinal Cord Injury

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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.Neuralink 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.