
Neuralink Gets FDA Approval For First In-Human Use of Brain Implants
In a significant milestone, Neuralink has received FDA approval for a groundbreaking clinical trial, known as the PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface). The study is set to commence following approval from an independent institutional review board and the first hospital site. This potentially pioneering medical device trial marks a leap forward in the development of a fully-implantable, wireless brain-computer interface (BCI). The primary aim of the PRIME Study is to assess the safety and initial functionality of the N1 Implant, a BCI implant, and the R1 Robot, a surgical robot, in enabling individuals with paralysis to control external devices using their thoughts.
The PRIME Study in a Nutshell
The N1 Implant, once surgically placed, becomes cosmetically invisible. It comprises 1024 electrodes distributed across 64 threads, each finer than a human hair. Its purpose is to record and transmit brain signals wirelessly to an app, which then decodes movement intentions. The initial goal of this BCI is to allow individuals to control a computer cursor or keyboard using only their thoughts.
The N1 Implant threads are so fine they can not be implanted by a human hand. Neuralink has also received FDA approval to use the R1 surgical robot in the study for device implantation.
The study is being conducted under the investigational device exemption (IDE) granted by the FDA in May 2023, representing a significant step in the mission to create a generalized brain interface for those with unmet medical needs, particularly individuals with quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS).
Study Participation and Requirements
To participate in the PRIME Study, individuals must meet specific criteria:
• Have quadriplegia due to spinal cord injury or ALS and be at least 1-year post-injury with no improvement.
• Be at least 22 years old.
• Have a consistent and reliable caregiver.
The study is anticipated to span approximately 6 years and will involve regular follow-ups with a team of experts to monitor the participants’ progress and ensure the Neuralink BCI continues to function as intended.
Study Phases
The PRIME Study comprises several phases, each serving a crucial role in assessing the viability and effectiveness of the BCI implant and surgical robot:
1. Primary Study: This phase involves a combination of 9 at-home and in-person clinic visits and spans approximately 18 months. During this period, participants will be closely monitored while using the N1 Implant and N1 User App to control a computer, providing valuable feedback about the system.
2. BCI Research Sessions: Participants will be asked to participate in BCI research sessions for the duration of the study, with a minimum commitment of 2 sessions per week, each lasting 1 hour.
3. Long-term Follow-up: After completing the Primary Study, participants will embark on a long-term follow-up phase lasting 5 years, with a total of 20 visits.
The Future of Brain-Computer Interfaces
The PRIME Study represents a potentially significant step towards unlocking the potential of BCIs in enhancing the lives of individuals with severe motor impairments. By enabling direct communication between the human brain and external devices, BCIs hold the promise of restoring autonomy and improving the quality of life for those with limited mobility. This groundbreaking trial paves the way for future advancements in the field of neurotechnology, offering hope to individuals who have long sought solutions to regain control over their lives through technology.