Precise Robotically IMplanted Brain-Computer InterfacE

NCT06429735 | Recruiting DMC FDA Device

• 1 other identifier: N1-EFS-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

spinal cord injury; SCI; BCI; brain computer interface; ALS; quadriplegia; tetraplegic; paralysis

Outcome Measures

Primary Outcomes (2)

• Device-Related Adverse Events (AE)

  12 months post-implant

• Procedure-Related Adverse Events (AE)

  12 months post-implant

Secondary Outcomes (2)

• Device-Related Adverse Events (AE)

  Up to 72 months post-implant

• Procedure-Related Adverse Events (AE)

  Up to 72 months post-implant

Study Arms (1)

Neuralink N1 Implant and R1 Robot

EXPERIMENTAL

Implantation of the N1 Implant by the R1 Robot.

Device: N1 Implant; Device: R1 Robot

Interventions

N1 Implant DEVICE

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

Also known as: Neuralink N1 Implant, N1, Telepathy, Link

Neuralink N1 Implant and R1 Robot

R1 Robot DEVICE

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

Also known as: R1, Neuralink R1 Robot

Neuralink N1 Implant and R1 Robot

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuralink Corp: lead

Study Sites (2)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Related Links

• https://neuralink.com/

MeSH Terms

Conditions

Quadriplegia; Amyotrophic Lateral Sclerosis; Paralysis; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Francisco Ponce, MD

  Barrow Neurological Institute

  PRINCIPAL INVESTIGATOR

• Jonathan Jagid, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neuralink Clinical Team

CONTACT

(877) 398-4465; clinical-team-ct@neuralink.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: January 9, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2031
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)