Menu
Recruiting NCT07127172

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

No phase Interventional Tetraplegia/Tetraparesis Quadriplegia Quadriplegia/Tetraplegia Cervical Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N1 Implant, R1 Robot.
Who it may be relevant to
Registry conditions: Tetraplegia/Tetraparesis, Quadriplegia, Quadriplegia/Tetraplegia, Cervical Spinal Cord Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device N1 Implant
    The N1 Implant is a type of implantable brain-computer interface.
  • Device R1 Robot
    The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Primary outcome measures

  • The Rate of Device-Related Adverse Events (AE) [Time frame: 12 months post-implant]
  • The Rate of Procedure-Related Adverse Events (AE) [Time frame: 12 months post-implant]
Secondary outcome measures (8)
  • The Rate of Device-Related Adverse Events (AE) [Time frame: Up to 48 months post-implant]
  • The Rate of Procedure-Related Adverse Events (AE) [Time frame: 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]
  • Change in Montreal Cognitive Assessment (MoCA) score during the Long-term Follow-up Phase [Time frame: 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]
  • 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]
  • 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]
  • 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]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United Kingdom · 2 centers
  • University College London Hospitals NHS Foundation Trust — London
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne

Identifiers

NCT: NCT07127172 · N1-EFS-006 · 354112

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗