Recruiting

Brain-Computer Interface

Sponsor:

Neuralink Corp

Code:

NCT06700304

Conditions

Tetraplegia/Tetraparesis

Quadriplegia

Quadriplegia/Tetraplegia

Cervical Spinal Cord Injury

Amyotrophic Lateral Sclerosis (ALS)

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

N1 Implant

R1 Robot

Study Details

Brief summary:

The CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.

Conditions

Tetraplegia/Tetraparesis

Quadriplegia

Quadriplegia/Tetraplegia

Cervical Spinal Cord Injury

Amyotrophic Lateral Sclerosis (ALS)

Study ID

NCT06700304

Start date

Nov 20, 2024

Status verified date

May, 2025

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface

Open label

Interventions

N1 Implant

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

R1 Robot

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

Primary outcome measure

  • The Rate of Device-Related Adverse Events (AE) [ Time Frame: 12 months post-implant ]
  • The Rate of Procedure-Related Adverse Events (AE) [ Time Frame: 12 months post-implant ]

Central Contacts and Locations

Central contacts

Neuralink Clinical Team

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

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Principal Investigator:

Dr. Andres Lozano

More Information

Sponsor

Neuralink Corp

Last update posted

May 31, 2025

Last verified

May, 2025

Keywords

  • brain computer interface
  • Neuralink N1 Implant
  • Neuralink
  • Robot
  • tetraparesis
  • tetraplegia
  • quadriplegia
  • ALS
  • spinal cord injury
  • Amyotrophic lateral sclerosis
  • chip
  • brain chip
  • External device control
  • Wireless implant
  • Neuroprosthetics
  • SCI
  • paralysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neuralink Corp on 2025-05-31.