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Clinical Trials in the USA / NCT06429735
Recruiting Not applicable

Precise Robotically IMplanted Brain-Computer InterfacE

NCT06429735 · tracked via the Priya Life Science USA tracker
Sponsor
Neuralink Corp
Phase
Not applicable
Started
2024-01-09
Last updated
2026-01-09

Condition(s) studied

Tetraplegia/TetraparesisQuadriplegiaCervical Spinal Cord InjuryAmyotrophic Lateral SclerosisQuadriplegia/TetraplegiaTetraplegic; Paralysis

Investigational drug(s) / intervention(s)

N1 ImplantR1 Robot

N1 Implant: The N1 Implant is a type of implantable brain-computer interface

R1 Robot: The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Study 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Barrow Neurological Institute Phoenix Arizona Recruiting
University of Miami Miami Florida Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06429735 on ClinicalTrials.gov ↗ ← All trials in the USA