NCT06700304 CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
| NCT ID | NCT06700304 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Neuralink Corp |
| Condition | Tetraplegia/Tetraparesis |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2027-11-30 |
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 6 participants in total. It began in 2024-11-20 with a primary completion date of 2027-11-30.
⚠ 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 CAN-PRIME Study is to test the safety and functionality of Neuralink's N1 Implant and R1 Robot in people who have difficulty moving their arms and legs (tetraparesis or tetraplegia). The N1 Implant is a small, wireless device placed in the skull. It connects to tiny threads inserted into the brain by the R1 Robot, which is a machine designed to carefully place these threads. This study will help researchers learn how well the implant and robot work and if they are safe for use.
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
Frequently Asked Questions
Who can join the NCT06700304 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, 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 NCT06700304 currently recruiting?
Yes, NCT06700304 is actively recruiting participants. Contact the research team at clinical-team-ct@neuralink.com for enrollment information.
Where is the NCT06700304 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06700304 clinical trial?
NCT06700304 is sponsored by Neuralink Corp. The trial plans to enroll 6 participants.