Tests a brain implant that lets paralyzed people control devices
Tests a brain implant and robot inserter in adults with paralysis from spinal injury.
Plain-language title generated from the registry record
Registry title: Precise Robotically IMplanted Brain-Computer InterfacE
Key facts
- Where
- Miami and Phoenix, United StatesSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Source: NCT06429735, who can take part
Where in United States
- University of MiamiMiami, United StatesTaking people
- Barrow Neurological InstitutePhoenix, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neuralink Corp
- Trial code
- NCT06429735
- Record updated
- 9 January 2026
- Original description
The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.Read full original descriptionShow less
PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.
Inclusion: Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below; Life expectancy ≥ 12 months; Ability to communicate in English; Presence of a stable caregiver.
Exclusion: 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; 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.