Robotically implanted Neuralink N1 brain-computer interface to control external devices
GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
This study will test whether a robotically implanted Neuralink N1 brain-computer interface can safely help people with high spinal cord injuries or ALS control computers and other external devices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neuralink Corp Industry-sponsored |
| Locations | 2 sites (London, Greater London and 1 other locations) |
| Trial ID | NCT07127172 on ClinicalTrials.gov |
What this trial studies
This is an early feasibility clinical study to examine the safety and functionality of the Neuralink N1 implant and the R1 robotic insertion system in people with severe upper-limb paralysis. The N1 is a wireless, rechargeable device mounted on the skull and connected to thin electrode threads that the R1 Robot inserts into the brain. Eligible participants have tetraparesis or tetraplegia from spinal cord injury, brainstem stroke, or progressive conditions such as ALS and will undergo robot-assisted implantation followed by training and regular follow-up visits. Outcomes will focus on perioperative safety, device performance, and the participant's ability to use the implant to control external devices while monitoring for adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults with non-ambulant bilateral upper-limb motor impairment from cervical spinal cord injury, brainstem stroke, or progressive conditions like ALS who are expected to reach severe tetraparesis, have life expectancy ≥12 months, can communicate in English, and have a stable caregiver.
Not a fit: Patients who are at high perioperative risk, have active implanted devices, morbid obesity (BMI > 40), very limited life expectancy, inability to communicate in English, or no reliable caregiver are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the device could restore hands-free control of phones, computers, and assistive technology and increase independence for people with severe upper-limb paralysis.
How similar studies have performed: Prior intracortical brain-computer interface studies using implanted microelectrode arrays have shown proof-of-concept for device and cursor control in small groups, but a fully wireless, robotically implanted system like the Neuralink N1 is novel and early in clinical testing.
Eligibility criteria
Show full inclusion / exclusion 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 this trial is running
London, Greater London and 1 other locations
- University College London Hospitals NHS Foundation Trust — London, Greater London, United Kingdom (Recruiting)
- The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, Tyne and Wear, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Neuralink Clinical Team
- Email: clinical-team-ct@neuralink.com
- Phone: (877) 398-4465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.