NCT06429735 Precise Robotically IMplanted Brain-Computer InterfacE
| NCT ID | NCT06429735 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuralink Corp |
| Condition | Tetraplegia/Tetraparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-01-09 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2024-01-09 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Francisco Ponce, MD
PRINCIPAL INVESTIGATOR
Barrow Neurological Institute
Frequently Asked Questions
Who can join the NCT06429735 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 75 Years, studying Tetraplegia/Tetraparesis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06429735 currently recruiting?
Yes, NCT06429735 is actively recruiting participants. Contact the research team at clinical-team-ct@neuralink.com for enrollment information.
Where is the NCT06429735 trial being conducted?
This trial is being conducted at Phoenix, United States, Miami, United States.
Who is sponsoring the NCT06429735 clinical trial?
NCT06429735 is sponsored by Neuralink Corp. The principal investigator is Francisco Ponce, MD at Barrow Neurological Institute. The trial plans to enroll 15 participants.