NCT06429735Recruiting
Precise Robotically IMplanted Brain-Computer InterfacE
PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
Source: ClinicalTrials.gov · Last updated 9 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 21 May 2024
- Start date
- 9 Jan 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- Neuralink Corp
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06429735
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 9 Jan 2024 to the primary completion date, Jun 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 22 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Barrow Neurological Institute Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.