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

NCT07127172 | Recruiting

• 2 other identifiers: N1-EFS-006354112
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Tetraplegia/Tetraparesis; Quadriplegia; Quadriplegia/Tetraplegia; Cervical Spinal Cord Injury; Amyotrophic Lateral Sclerosis (ALS); Spinal Cord Injury (Quadraplegia); Spinal Cord Injury; Motor Neuron Disease; Brain Stem Stroke

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; motor neuron disease

Outcome Measures

Primary Outcomes (2)

• The Rate of Device-Related Adverse Events (AE)

  12 months post-implant

• The Rate of Procedure-Related Adverse Events (AE)

  12 months post-implant

Secondary Outcomes (8)

• The Rate of Device-Related Adverse Events (AE)

  Up to 48 months post-implant

• The Rate of Procedure-Related Adverse Events (AE)

  Up to 48 months post-implant

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

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

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

  From baseline to 48-months post-implantation

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

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

Study Arms (1)

GB-PRIME: Precise Robotically Implanted Brain-Computer Interface

OTHER

Open label

Device: N1 Implant; Device: R1 Robot

Interventions

N1 Implant DEVICE

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

GB-PRIME: Precise Robotically Implanted Brain-Computer Interface

R1 Robot DEVICE

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

GB-PRIME: Precise Robotically Implanted Brain-Computer Interface

Eligibility Criteria

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

You may qualify if:

• (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

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

Study Sites (2)

University College London Hospitals NHS Foundation Trust

London, Greater London, WC1N 3BG, United Kingdom

RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne and Wear, NE2 4HH, United Kingdom

RECRUITING

Related Links

• Neuralink UK Patient Registry
• Neuralink Website

MeSH Terms

Conditions

Quadriplegia; Amyotrophic Lateral Sclerosis; Spinal Cord Injuries; Motor Neuron Disease; Brain Stem Infarctions; Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

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

Model Details: The study is a pre UKCA/CE, prospective, longitudinal, non-randomized, open-label, single-arm early feasibility study (EFS)

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 17, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2031
• Last Updated: August 17, 2025

Record last verified: 2025-07

Locations

GB (2)