CAN-PRIME: Precise Robotically Implanted Brain-Computer Interface for the Control of External Devices

Launched by NEURALINK CORP · Nov 19, 2024

Keywords

ClinConnect Summary

The CAN-PRIME Study is a clinical trial designed to test a new technology called the Neuralink N1 Implant, along with a robot that helps place it in the brain. This study is focused on individuals who have severe difficulty moving their arms and legs due to conditions like tetraplegia from spinal cord injuries or amyotrophic lateral sclerosis (ALS). The goal is to see if this implant can safely help people regain some control over external devices, potentially improving their quality of life.

To participate in this study, candidates must have severe quadriplegia for at least one year, be able to communicate in English, and have a stable caregiver. Participants should expect to have a small device implanted in their skull, which connects to tiny threads in the brain, allowing for potential communication with devices like computers or wheelchairs. It’s important to note that not everyone will be eligible; conditions like obesity, certain medical histories, and active implanted devices may prevent participation. Overall, this trial aims to explore a promising technology that could help those with significant mobility challenges.

Gender

ALL

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