NCT07127172 GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
| NCT ID | NCT07127172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuralink Corp |
| Condition | Tetraplegia/Tetraparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 7 participants |
| Start Date | 2025-07-31 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 7 participants in total. It began in 2025-07-31 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07127172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tetraplegia/Tetraparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07127172 currently recruiting?
Yes, NCT07127172 is actively recruiting participants. Contact the research team at clinical-team-ct@neuralink.com for enrollment information.
Where is the NCT07127172 trial being conducted?
This trial is being conducted at London, United Kingdom, Newcastle upon Tyne, United Kingdom.
Who is sponsoring the NCT07127172 clinical trial?
NCT07127172 is sponsored by Neuralink Corp. The trial plans to enroll 7 participants.