Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07127172

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

The GB-PRIME Study is an early feasibility study designed to assess the clinical safety and functionality of the Neuralink N1 Implant and R1 Robot. This study involves participants who have tetraparesis, tetraplegia, or a diagnosis that may lead to these conditions.

The N1 Implant is a wireless, rechargeable device mounted on the skull, connected to electrode threads that are inserted into the brain by the R1 Robot, which is a robotic device specifically designed for this procedure.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Tetraplegia/Tetraparesis Amyotrophic Lateral Sclerosis Amyotrophic Lateral Sclerosis (ALS) Brain Diseases Brain Infarction Brain Ischemia Brain Stem Infarctions Brain Stem Stroke Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cervical Spinal Cord Injury Infarction Ischemia Metabolic Diseases Motor Neuron Disease Necrosis Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Neuromuscular Diseases Nutritional and Metabolic Diseases Paralysis Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Quadriplegia Quadriplegia/Tetraplegia Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Spinal Cord Injury (Quadraplegia) Stroke TDP-43 Proteinopathies Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London Hospitals NHS Foundation Trust, London, Greater London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • (a) A diagnosis of a spinal cord injury, brain stem stroke, or other neurological condition causing the participant to be non-ambulant and with bilateral upper limb motor impairment with no expectation of recovery that significantly or completely impairs the participant's ability to manually control a computer, smartphone or tablet with their hands.

OR (b) A diagnosis of Amyotrophic Lateral Sclerosis (ALS) or other progressive neurological condition where the natural history of the disease is well understood and where there is tetraparesis and the expectation in the view of the participants treating neurologist that the disease will progress such that the participant will meet 1a within 1 year of recruitment.

  • 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.

R1 Robot

Device

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

Primary outcomes

  1. The Rate of Device-Related Adverse Events (AE)

    Time frame: 12 months post-implant

  2. The Rate of Procedure-Related Adverse Events (AE)

    Time frame: 12 months post-implant

Secondary outcomes

  1. The Rate of Device-Related Adverse Events (AE)

    Time frame: Up to 48 months post-implant

  2. The Rate of Procedure-Related Adverse Events (AE)

    Time frame: Up to 48 months post-implant

  3. Change in Montreal Cognitive Assessment (MoCA) score during the Primary Study

    Time frame: From baseline to 3-, 6-, 9-, and 12-months post-implantation

    The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit.

  4. Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase

    Time frame: From baseline to 48-months post-implantation

    The Montreal Cognitive Assessment (MoCA) is a 30-point scale assessing cognitive function. Scores range from 0 to 30, with higher scores indicating better cognitive performance. Outcome will be reported as change from baseline at each follow-up visit.

  5. Change in Patient Health Questionnaire-9 (PHQ-9) score during the Primary Study

    Time frame: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale used to assess depression severity. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Outcome will be reported as change from baseline at each follow-up visit.

  6. Change in Patient Health Questionnaire-9 (PHQ-9) score during the Long-term Follow-up Phase

    Time frame: From baseline to 48-months post-implantation

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item scale used to assess depression severity. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Outcome will be reported as change from baseline at each follow-up visit.

  7. Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Primary Study

    Time frame: From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation

    The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety severity. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Outcome will be reported as change from baseline at each follow-up visit.

  8. Change in Generalized Anxiety Disorder-7 (GAD-7) score during the Long-term Follow-up Phase

    Time frame: From baseline to 48-months post-implantation

    The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses anxiety severity. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Outcome will be reported as change from baseline at each follow-up visit.

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

Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust
  • University College London Hospitals

Registry information

Acronym: GB-PRIME

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.