Precise Robotically IMplanted Brain-Computer InterfacE

NCT06429735 — Not applicable, Recruiting, 15 participants, Neuralink Corp

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PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Registry	NCT06429735, acronym PRIME
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, device feasibility
Enrollment	15 (Estimated)
Sponsor	Neuralink Corp (Industry)
Conditions	Tetraplegia/Tetraparesis, Quadriplegia, Cervical Spinal Cord Injury, Amyotrophic Lateral Sclerosis, Quadriplegia/Tetraplegia, Tetraplegic; Paralysis
Interventions	N1 Implant, R1 Robot (Device)
Dates	start 2024-01-09, primary completion 2026-06-01 (estimated), completion 2031-01-01 (estimated), first posted 2024-05-28, last updated 2026-01-09
Locations	2 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Neuralink N1 Implant and R1 Robot	Experimental	Device: N1 Implant; Device: R1 Robot	Implantation of the N1 Implant by the R1 Robot.

N1 Implant (Device), also known as Neuralink N1 Implant, N1, Telepathy, Link: The N1 Implant is a type of implantable brain-computer interface
R1 Robot (Device), also known as R1, Neuralink R1 Robot: The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

+Outcome measures

Primary outcomes

Device-Related Adverse Events (AE) [12 months post-implant]
Procedure-Related Adverse Events (AE) [12 months post-implant]

Secondary outcomes

Device-Related Adverse Events (AE) [Up to 72 months post-implant]
Procedure-Related Adverse Events (AE) [Up to 72 months post-implant]

+Eligibility

Sex: All, ages: 22 Years to 75 Years

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

+Locations (2)

Facility	City	Country	Status
Barrow Neurological Institute	Phoenix, Arizona	United States	Recruiting
University of Miami	Miami, Florida	United States	Recruiting

+Investigators

Francisco Ponce, MD, Principal investigator, Barrow Neurological Institute
Jonathan Jagid, MD, Principal investigator, University of Miami