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Neuralink Receives Health Canada Approval for Brain-Computer Interface Trial

• Neuralink has received Health Canada approval to launch its first global trial, CAN-PRIME, evaluating its implantable brain-computer interface (BCI) device. • The CAN-PRIME trial will assess the safety of Neuralink’s implant and surgical robot, as well as the preliminary functionality of the BCI in quadriplegic individuals. • The trial will recruit Canadian residents with ALS or cervical spinal cord injury, focusing on those with limited or no hand use. • University Health Network (UHN) hospital in Toronto will be the exclusive Canadian site for the wireless BCI implantation procedure.

Neuralink has secured approval from Health Canada to initiate the 'Canadian Precise Robotically Implanted Brain-Computer Interface' (CAN-PRIME) trial, marking the first global study of its implantable device. The trial aims to evaluate the safety and initial functionality of Neuralink's brain-computer interface (BCI) in assisting individuals with quadriplegia to control external devices using their cognitive abilities.
The University Health Network (UHN) hospital, specifically Toronto Western Hospital, has been selected as the exclusive site for this pioneering study. The procedure involves implanting a wireless BCI using advanced surgical techniques.

CAN-PRIME Trial Details

The CAN-PRIME trial is designed to assess the safety of Neuralink’s implant and surgical robot, while also exploring the preliminary functionality of the BCI. The study focuses on individuals with tetraparesis or tetraplegia, specifically Canadian residents diagnosed with amyotrophic lateral sclerosis (ALS) or cervical spinal cord injury who have limited or no use of both hands.
The N1 Implant, a compact wireless device, will be placed within the skull and connected to the brain via threads positioned by the R1 Robot. This study is crucial in determining the safety of both the implant and the robotic surgical system.

Expert Perspectives

UHN president and CEO Dr. Kevin Smith emphasized the significance of this milestone, stating, “This progress is a testament to the dedication and expertise of our world-leading medical and research professionals, as well as our commitment to providing the most innovative and effective treatments for patients. As the first and exclusive surgical site in Canada to perform this procedure, we will continue to shape the future of neurological care and further define our track record for doing what hasn’t been done.”

Comparison to US-Based PRIME Study

The CAN-PRIME study follows Neuralink’s US-based PRIME study, conducted at the Barrow Neurological Institute. In the US study, a participant who received the Neuralink implant ('Link') demonstrated progress in using digital devices and effectively utilizing computer-aided design (CAD) software to design 3D objects post-surgery.

Breakthrough Device Designation

In September, Neuralink received breakthrough device status from the US Food and Drug Administration for its 'Blindsight device'.
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Reference News

[1]
Neuralink receives Health Canada approval to launch trial of implantable device
clinicaltrialsarena.com · Nov 22, 2024

Neuralink receives Health Canada approval for CAN-PRIME trial to assess safety and functionality of its implantable brai...

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