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PRIME Study: N1 Implant for Quadriplegia

The PRIME Study is an early study testing the safety and function of the Neuralink N1 Implant and R1 Robot. The N1 Implant is a small device placed in the skull, connected to tiny threads that go into the brain. The R1 Robot helps to precisely place these threads. This study is for people aged 22 to 75 who have severe quadriplegia (very limited or no hand, wrist, and arm movement) due to a spinal cord injury or ALS (amyotrophic lateral sclerosis) for at least one year. The main goal is to see if the N1 Implant and R1 Robot cause any problems (adverse events) within 12 months after the implant. The study plans to enroll 15 participants, but its current status is unclear.

Study design
This is a first-in-human early feasibility study, meaning it's one of the first times this device is being tested in people. It plans to enroll 15 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after the implant to check for any device-related or procedure-related problems.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06429735

Precise Robotically IMplanted Brain-Computer InterfacE

Recruiting
NAAges 22–75InterventionalDevice feasibility
Neuralink Corp
~15 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:N1 ImplantR1 Robot

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device-Related Adverse Events (AE)
Measured over 12 months post-implant
+1 more outcome measured

Conditions

Tetraplegia/Tetraparesis
Quadriplegia
Cervical Spinal Cord Injury
Amyotrophic Lateral Sclerosis
Quadriplegia/Tetraplegia
Tetraplegic; Paralysis

Explore related trials

Amyotrophic Lateral SclerosisQuadriplegiaSpinal Cord Injury

Where it's being run

2 sites across 2 states
Arizona1
Florida1

Study leadership

  • Francisco Ponce, MD · PRINCIPAL_INVESTIGATOR · Barrow Neurological Institute
  • Jonathan Jagid, MD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Neuralink Clinical Team
[email protected]
(877) 398-4465
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

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