Precise Robotically IMplanted Brain-Computer InterfacE

Launched by NEURALINK CORP · May 21, 2024

Keywords

ClinConnect Summary

The PRIME Study is an exciting clinical trial aimed at helping individuals with severe paralysis, such as tetraplegia or conditions like amyotrophic lateral sclerosis (ALS). This study is testing a new device called the Neuralink N1 Implant, which is a small, wireless device placed in the skull that connects to tiny electrode threads implanted in the brain using a special robot. The goal is to see if this device is safe and how well it works in allowing participants to communicate and interact with the world around them.

To be eligible for this study, participants should have had severe paralysis for at least a year and must be able to communicate in English. They will need a stable caregiver to help them during the trial. Participants can expect to undergo a procedure where the device is implanted, and they will be closely monitored for safety and device functionality. It’s important to note that certain medical conditions, like uncontrolled seizures or the presence of other implanted devices, could prevent someone from joining the study. This trial could pave the way for new treatments that improve the quality of life for those with severe mobility limitations.

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