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Precise Robotically IMplanted Brain-Computer InterfacE

NCT06429735 · Neuralink Corp
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
About this study
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 criteria
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
Study design
Enrollment target: 15 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-01-09
Estimated completion: 2031-01
Last updated: 2026-01-09
Interventions
Device: N1 ImplantDevice: R1 Robot
Primary outcomes
  • Device-Related Adverse Events (AE) (12 months post-implant)
  • Procedure-Related Adverse Events (AE) (12 months post-implant)
Sponsor
Neuralink Corp · industry
Contacts & investigators
ContactNeuralink Clinical Team · contact · clinical-team-ct@neuralink.com · (877) 398-4465
InvestigatorFrancisco Ponce, MD · principal_investigator, Barrow Neurological Institute
InvestigatorJonathan Jagid, MD · principal_investigator, University of Miami
All locations (2)
Barrow Neurological InstituteRecruiting
Phoenix, Arizona, United States
University of MiamiRecruiting
Miami, Florida, United States
Precise Robotically IMplanted Brain-Computer InterfacE · TrialPath