Robotically implanted brain-computer interface for controlling devices
CAN-PRIME: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices
This study is testing a new brain implant and robot to see if they can help people with severe movement limitations control devices more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Neuralink Corp Industry-sponsored |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06700304 on ClinicalTrials.gov |
What this trial studies
This study tests the safety and functionality of Neuralink's N1 Implant and R1 Robot in individuals with severe movement limitations due to conditions like tetraplegia or ALS. The N1 Implant is a small, wireless device implanted in the skull, which connects to fine threads inserted into the brain by the R1 Robot. The goal is to evaluate how effectively the implant and robot work together to assist patients in controlling external devices. Participants will be monitored for safety and functionality over the course of the study.
Who should consider this trial
Good fit: Ideal candidates are individuals with severe quadriplegia due to spinal cord injury or ALS, who have had limited or no movement for at least one year.
Not a fit: Patients with moderate to high risk for serious perioperative adverse events or those with active implanted devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this technology could significantly enhance the quality of life for patients with severe mobility impairments by enabling them to control devices with their thoughts.
How similar studies have performed: Other studies involving brain-computer interfaces have shown promise, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Neuralink Clinical Team
- Email: clinical-team-ct@neuralink.com
- Phone: (877) 398-4465
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.