NCT07127172Recruiting
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Source: ClinicalTrials.gov · Last updated 17 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 7 (estimated)
- First submitted
- 31 Jul 2025
- Start date
- 31 Jul 2025
- Primary completion date
- Jan 2028
- Lead sponsor
- Neuralink Corp
- Diseases
- ALS (motor neurone disease), Stroke
- NCT number
- NCT07127172
What you commit to
- Study type: Interventional
- Planned participants: 7
- From 31 Jul 2025 to the primary completion date, Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of poorly controlled seizures or epilepsy
- History of poorly controlled diabetes
- Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
- 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
Other
- Moderate to high risk for serious perioperative adverse events
- Active implanted devices
- Morbid obesity (Body Mass Index \> 40)
- Acquired or hereditary immunosuppression
- Use of smoking tobacco or other tobacco products
Who the study is looking for
- (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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College London Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.