Neuralink has initiated its CAN-PRIME clinical trial in Canada, marking the first international expansion of its brain-computer interface (BCI) research. The University Health Network (UHN) in Toronto will serve as the exclusive Canadian site for the trial, focusing on individuals with quadriplegia resulting from amyotrophic lateral sclerosis (ALS) or spinal cord injury.
The CAN-PRIME trial (NCT06700304) aims to enroll up to six adult participants, aged 19 and older, who will be followed for six years. This follows Health Canada's clearance, allowing Neuralink to extend its BCI research beyond the ongoing PRIME study (NCT06429735) in the United States.
Neuralink's Technology and Trial Design
The Neuralink device, known as the N1 implant, is surgically placed in the brain region responsible for movement intention. It is designed to enable individuals with limited or no limb function to control external devices using their thoughts. The PRIME study in the U.S. is recruiting up to five participants, aged 22-75, with a subsequent CONVOY trial (NCT06710626) planned to assess the use of the N1 implant for controlling devices like robotic arms.
Andres Lozano, PhD, UHN neurosurgery chair and lead investigator for the CAN-PRIME study, stated, "This landmark surgery has the potential to transform and improve outcomes for patients who previously had limited options."
Restoring Independence Through Brain-Computer Interfaces
ALS, a progressive neurodegenerative disease, and spinal cord injuries often lead to loss of limb movement and impaired speech. The inability to communicate effectively severely impacts patients' quality of life. Neuralink's BCI technology offers a potential solution by translating intended-movement brain signals into actions, allowing users to operate external devices without physical movement. Other BCI devices have also demonstrated promise in assisting ALS patients.
The N1 implant features ultra-thin, flexible threads designed to minimize tissue damage during implantation. A specialized surgical robot, the R1 Robot, is used to precisely and safely insert these threads into the brain. The device is encased in a durable enclosure to protect it from moisture and contaminants.
Once implanted, the N1 device processes brain signals using low-power electronics and transmits them wirelessly to the Neuralink N1 user app. This app interprets the patient's intended movements, such as typing or navigating a smartphone, and translates them into corresponding actions.
Evaluating Safety and Functionality
CAN-PRIME will primarily evaluate the safety and functionality of the N1 device, the R1 robot, and the BCI software. The surgical procedure will be performed by a team of surgeons, scientists, and medical experts at UHN's Toronto Western Hospital, specializing in neurology.
To be eligible for the study, participants must have severe quadriplegia due to ALS or a spinal cord injury for at least one year without improvement. Additional criteria include a life expectancy of at least 12 months, the ability to communicate in English, and the presence of a stable caregiver. Participants will be reimbursed for study-related travel expenses.
The study is structured into an 18-month primary study stage followed by a five-year follow-up period. Regular monitoring will be conducted through at-home and in-person clinic visits, along with at least two BCI research sessions per week.
Bradly Wouters, PhD, executive vice president of science and research at UHN, commented, "This is a perfect example of how scientific discovery, technological innovation, and clinical expertise come together to develop new approaches to continuously improve patient care."
