Robotically implanted brain-computer interface for patients with severe paralysis
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 that uses a robot to help people with severe paralysis communicate and control devices better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 22 Years to 75 Years |
| Sex | All |
| Sponsor | Neuralink Corp Industry-sponsored |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Trial ID | NCT06429735 on ClinicalTrials.gov |
What this trial studies
The PRIME Study is an early feasibility assessment aimed at evaluating the safety and functionality of the Neuralink N1 Implant and R1 Robot in individuals suffering from severe quadriplegia or tetraparesis due to spinal cord injury or ALS. This innovative approach involves a wireless, rechargeable implant that connects to electrode threads inserted into the brain by a robotic device. The study seeks to determine how effectively this technology can restore communication and control for patients with significant motor impairments.
Who should consider this trial
Good fit: Ideal candidates are individuals with severe quadriplegia or tetraparesis due to spinal cord injury or ALS, who have had no improvement 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 paralysis by enabling them to control devices and communicate more effectively.
How similar studies have performed: While this approach is novel, similar studies involving brain-computer interfaces have shown promise in preliminary phases.
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
Phoenix, Arizona and 1 other locations
- Barrow Neurological Institute — Phoenix, Arizona, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Francisco Ponce, MD — Barrow Neurological Institute
- 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.