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

August 11, 2025 updated by: Neuralink Corp

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, WC1N 3BG
        • Recruiting
        • University College London Hospitals Nhs Foundation Trust
        • Principal Investigator:
          • Mr. Harith Akram, MBChB, PhD, FRCS (Neuro.Surg)
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE2 4HH
        • Recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Mr. Mohammed Hussain, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: GB-PRIME: Precise Robotically Implanted Brain-Computer Interface
Open label
Device: R1 Robot
The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.
Device: N1 Implant
The N1 Implant is a type of implantable brain-computer interface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Rate of Device-Related Adverse Events (AE)
Time Frame: 12 months post-implant
12 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time Frame: 12 months post-implant
12 months post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Rate of Device-Related Adverse Events (AE)
Time Frame: Up to 48 months post-implant
Up to 48 months post-implant
The Rate of Procedure-Related Adverse Events (AE)
Time Frame: Up to 48 months post-implant
Up to 48 months post-implant
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.
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
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.
From baseline to 48-months post-implantation
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.
From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation
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.
From baseline to 48-months post-implantation
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.
From baseline to 1-, 3-, 6-, 9-, and 12-months post-implantation
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.
From baseline to 48-months post-implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neuralink Corp

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2031

Study Registration Dates

First Submitted

July 31, 2025

First Submitted That Met QC Criteria

August 11, 2025

First Posted (Actual)

August 17, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N1-EFS-006
  • 354112 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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