Actively Recruiting
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Led by Neuralink Corp · Updated on 2025-08-17
7
Participants Needed
2
Research Sites
161 weeks
Total Duration
On this page
Sponsors
N
Neuralink Corp
Lead Sponsor
N
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and functionality of the Neuralink N1 Implant and R1 Robot in people who have tetraparesis, tetraplegia, or similar neurological conditions. This early feasibility study focuses on those with spinal cord injury, brain stem stroke, or progressive diseases like Amyotrophic Lateral Sclerosis (ALS), which cause severe upper limb motor impairment. The study aims to understand how well this brain-computer interface device and its robotic implantation system work in this population. The N1 Implant is a wireless, rechargeable device mounted on the skull, with electrode threads inserted into the brain using the R1 Robot, a specialized robotic inserter. Participants receive the implant through a surgical procedure, and the study is open label, meaning everyone knows the treatment being given. The study includes a primary phase and a long-term follow-up to monitor outcomes over time. Participants will be closely monitored through various assessments including tracking device- and procedure-related adverse events up to 48 months after implantation. Cognitive function and mental health will be evaluated using tools such as the Montreal Cognitive Assessment (MoCA), Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder-7 (GAD-7) at multiple timepoints. The study is designed to last several years, providing detailed safety and functional data for this brain-computer interface system.
CONDITIONS
Brief Title
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of spinal cord injury, brain stem stroke, or neurological condition causing inability to walk and severe bilateral upper limb motor impairment preventing manual control of computer, smartphone, or tablet
- OR diagnosis of ALS or progressive neurological disease expected to progress to above condition within 1 year as judged by neurologist
- Life expectancy of at least 12 months
- Ability to communicate in English
- Has a stable caregiver
You will not qualify if you...
- Moderate to high risk for serious perioperative adverse events
- Presence of active implanted devices
- Morbid obesity (Body Mass Index greater than 40)
- History of poorly controlled seizures or epilepsy
- History of poorly controlled diabetes
- Requires MRI for ongoing medical conditions
- Acquired or hereditary immunosuppression
- Use of smoking tobacco or other tobacco products
- Psychiatric or psychological disorder
- Brain MRI showing hemorrhage, tumor, or adverse anatomy
- Any condition compromising safe participation or implantation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo robotic implantation of the N1 brain-computer interface device using the R1 Robot.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for device- and procedure-related adverse events and assessed for cognitive and psychological changes during the first 12 months after implantation.
Multiple visits up to 12 months post-implant
Duration - Up to 48 months post-implant
Participants continue to be monitored for adverse events and clinical changes up to 48 months after implantation.
Periodic visits during long-term follow-up
Trial Site Locations
Total: 2 locations
1
University College London Hospitals NHS Foundation Trust
London, Greater London, United Kingdom, WC1N 3BG
Actively Recruiting
2
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE2 4HH
Actively Recruiting
Research Team
N
Neuralink Clinical Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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