GB-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
About this trial
This trial is enrolling 7 individuals with cervical spinal cord injury, or other conditions causing loss of function in all four extremities (tetraparesis) to evaluate the safety and functionality of a robot implanted brain-computer-interface device, the Neuralink N1. The N1 uses electrode threads inserted into the brain to record brain activity. The electrical signals from these electrodess are then processed and decoded by a computer, allowing the user to control external digital devices. If included, participants will receive the skull-mounted, wireless, rechargeable N1 device, implanted in the brain by a robotic inserter. Final testing of device functionality and safety will be performed after 4 years.
Included participants
What’s involved
Type
Details
- Participants will receive the skull-mounted, wireless, rechargeable Neuralink N1 device, implanted in the brain by a robotic inserter (R1). - The N1 uses electrode threads in the brain to record brain activity. These signals are then processed and decoded by a computer allowing the user to control external digital devices. - Final testing of device functionality and safety will be performed after 4 years.
Potential benefits
Main benefits
General health
Additional benefits
Mental health and psychosocial factors
Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more- Trial recruitment status
- Recruiting
- Trial start date
- 31 Jul 2025
- Organisation
- Neuralink Corp
- Trial recruitment status
- Recruiting
- Trial start date
- 31 Jul 2025
- Organisation
- Neuralink Corp
About this trial
Included participants
What’s involved
Potential benefits
Wings for Life supports SCITrialsFinder
Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.
Learn more