Precise Robotically IMplanted Brain-Computer InterfacE

Not Applicable

Recruiting

• Conditions: Tetraplegia/Tetraparesis; Quadriplegia; Cervical Spinal Cord Injury; Quadriplegia/Tetraplegia; Tetraplegic; Paralysis; Amyotrophic Lateral Sclerosis
• Interventions: Device: N1 Implant; Device: R1 Robot

• Registration Number: NCT06429735
• Lead Sponsor: Neuralink Corp

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-09
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2026-01
• Study Completion: 2031-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neuralink N1 Implant and R1 Robot	N1 Implant	Implantation of the N1 Implant by the R1 Robot.
Neuralink N1 Implant and R1 Robot	R1 Robot	Implantation of the N1 Implant by the R1 Robot.

Primary Outcome Measures

Name	Time	Method
Device-Related Adverse Events (AE)	12 months post-implant
Procedure-Related Adverse Events (AE)	12 months post-implant

Secondary Outcome Measures

Name	Time	Method
Procedure-Related Adverse Events (AE)	Up to 72 months post-implant
Device-Related Adverse Events (AE)	Up to 72 months post-implant

Trial Locations

Locations (1)

Barrow Neurological Institute; 🇺🇸 Phoenix, Arizona, United States