Precise Robotically IMplanted Brain-Computer InterfacE

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified December 2025 by Neuralink Corp
Sponsor
Neuralink Corp
Information Provided by (Responsible Party)
Neuralink Corp
Clinicaltrials.gov Identifier
NCT06429735
Other Study ID Numbers:
N1-EFS-001
First Submitted
May 20, 2024
First Posted
May 27, 2024
Last Update Posted
January 8, 2026
Last Verified
December 2025

ClinicalTrials.gov processed this data on January 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Tetraplegia/TetraparesisQuadriplegiaCervical Spinal Cord InjuryAmyotrophic Lateral SclerosisQuadriplegia/TetraplegiaTetraplegic; Paralysis
Device: N1 Implant

Study Design

Study TypeInterventional
Actual Enrollment15 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeDevice Feasibility
Official TitlePRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Study Start DateJanuary 8, 2024
Actual Primary Completion Date2w 3d from now
Actual Study Completion Date4yrs 7mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Neuralink N1 Implant and R1 Robot
Implantation of the N1 Implant by the R1 Robot.
Device: N1 Implant
The N1 Implant is a type of implantable brain-computer interface

Outcome Measures

Primary Outcome Measures
  1. Device-Related Adverse Events (AE)
  2. Procedure-Related Adverse Events (AE)
Secondary Outcome Measures
  1. Device-Related Adverse Events (AE)
  2. Procedure-Related Adverse Events (AE)

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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
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

Contacts and Locations

Sponsors and CollaboratorsNeuralink Corp
Locations
Barrow Neurological Institute | Phoenix Arizona, United States, 85013University of Miami | Miami Florida, United States, 33136
Investigators
Principal Investigator: Francisco Ponce, MD, Barrow Neurological InstitutePrincipal Investigator: Jonathan Jagid, MD, University of Miami