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

Launched by NEURALINK CORP · Aug 11, 2025

Keywords

ClinConnect Summary

This clinical trial, called GB-PRIME, is exploring a new technology designed to help people who have lost the use of their arms and hands due to conditions like spinal cord injury, ALS, or brain stem stroke. The study is testing a small, wireless device called the Neuralink N1 Implant, which is placed on the skull and connected to tiny threads inserted into the brain by a special robot. The goal is to see if this device can safely and effectively help participants control external devices like computers or smartphones using their brain signals.

People who might be able to join the study include those who cannot walk and have severe weakness or paralysis in both arms and hands, with little chance of improvement. This also includes people with ALS or similar conditions expected to worsen over the next year. Participants need to have a life expectancy of at least one year, speak English, and have a stable caregiver to support them. The study team will carefully check each person’s health to make sure it’s safe to take part, excluding those with certain medical risks or other conditions that could make the surgery or study unsafe. If accepted, participants will have the implant placed using the robot, and researchers will monitor how well the device works and how safe it is over time.

Gender

ALL

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