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

Sponsor: Neuralink Corp

NCT ID: NCT07127172

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
N1 Implant (device), R1 Robot (device)
How long the study runs
Study runs about 67 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
7
Started
2025-07-31
Last checked
2025-07

Plain English Summary

What is this study?

  • • Testing a new treatment for tetraplegia/tetraparesis
  • • NA - 7 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with tetraplegia/tetraparesis

Where?

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

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Tetraplegia/TetraparesisQuadriplegiaQuadriplegia/TetraplegiaCervical Spinal Cord InjuryAmyotrophic Lateral Sclerosis (ALS)Spinal Cord Injury (Quadraplegia)Spinal Cord InjuryMotor Neuron DiseaseBrain Stem Stroke

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Life expectancy ≥ 12 months.
  • ✓Ability to communicate in English
  • ✓Presence of a stable caregiver

Who cannot take part

  • ✗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
See the full criteria
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

Where Is This Study? (2 UK sites)

University College London Hospitals NHS Foundation Trust

London WC1N 3BG, United Kingdom

Recruiting
Site contact (verified)
Mr. Harith Akram, MBChB, PhD, FRCS (Neuro.Surg)Principal Investigator

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne NE2 4HH, United Kingdom

Recruiting
Site contact (verified)
Mr. Mohammed Hussain, MDPrincipal Investigator

How to Get in Touch

Neuralink Clinical Team

Sponsor contact

CONTACT

(877) 398-4465 clinical-team-ct@neuralink.com
Data sourced from ClinicalTrials.gov · Last verified: 2025-07