Precise Robotically IMplanted Brain-Computer InterfacE

NCT ID: NCT06429735

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-09

Study Completion Date

2031-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Neuralink N1 Implant and R1 Robot

Implantation of the N1 Implant by the R1 Robot.

Group Type EXPERIMENTAL

N1 Implant

Intervention Type DEVICE

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

R1 Robot

Intervention Type DEVICE

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

Interventions

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N1 Implant

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

Intervention Type DEVICE

R1 Robot

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

Intervention Type DEVICE

Other Intervention Names

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Neuralink N1 Implant, N1, Telepathy, Link R1, Neuralink R1 Robot

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neuralink Corp

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francisco Ponce, MD

Role: PRINCIPAL_INVESTIGATOR

Barrow Neurological Institute

Jonathan Jagid, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status RECRUITING

University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Neuralink Clinical Team

Role: CONTACT

(877) 398-4465

Related Links

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https://neuralink.com/

https://neuralink.com/

Other Identifiers

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N1-EFS-001

Identifier Type: -

Identifier Source: org_study_id

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