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NCT Number: NCT06429735

Precise Robotically IMplanted Brain-Computer InterfacE

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.

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Key information

Conditions

Tetraplegia/Tetraparesis Amyotrophic Lateral Sclerosis Central Nervous System Diseases Cervical Spinal Cord Injury Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Quadriplegia/Tetraplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries TDP-43 Proteinopathies Tetraplegic; Paralysis Trauma, Nervous System Wounds and Injuries

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barrow Neurological Institute, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N1 Implant

Device

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

Other names: Neuralink N1 Implant, N1, Telepathy, Link

R1 Robot

Device

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

Other names: R1, Neuralink R1 Robot

Primary outcomes

  1. Device-Related Adverse Events (AE)

    Time frame: 12 months post-implant

  2. Procedure-Related Adverse Events (AE)

    Time frame: 12 months post-implant

Secondary outcomes

  1. Device-Related Adverse Events (AE)

    Time frame: Up to 72 months post-implant

  2. Procedure-Related Adverse Events (AE)

    Time frame: Up to 72 months post-implant

Study contacts

Contact information is provided by the study sponsor or research team.

Neuralink Clinical Team

CONTACT

[email protected]

(877) 398-4465

Sponsors and collaborators

Lead sponsor

Neuralink Corp

Industry

Registry information

Official study title

PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Acronym: PRIME

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
May 28, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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