Neuralink, a neurotech startup founded by Elon Musk, has begun its first in-human clinical trial, known as the PRIME Study (Precise Robotically Implanted Brain-Computer Interface). The trial aims to evaluate the safety of Neuralink's fully-implantable, wireless brain-computer interface (BCI) and surgical robot (R1), and assess the initial functionality of the BCI for enabling people with paralysis to control external devices with their thoughts. The study is being conducted under the investigational device exemption (IDE) awarded by the FDA in May 2023. The trial will involve the use of the R1 Robot to surgically place the N1 Implant's ultra-fine and flexible threads in a region of the brain that controls movement intention. Once in place, the N1 Implant is intended to record and transmit brain signals wirelessly to an app that decodes movement intention. The initial goal of the BCI is to allow people to control a computer cursor or keyboard using their thoughts alone. The trial is open to individuals who have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS). However, the exact number of participants to be enrolled in the trial, which is expected to take about six years to complete, has not been disclosed. It's important to note that Neuralink's journey to this point has not been without controversy. The company has faced scrutiny over its handling of animal experiments, with allegations of rushed and botched surgeries leading to unnecessary animal deaths. Despite these concerns, the FDA approved Neuralink's application for human trials in May 2023. Elon Musk has ambitious plans for Neuralink, envisioning that brain implants could cure a range of conditions including obesity, autism, depression, and schizophrenia, as well as enabling web browsing and telepathy. However, experts suggest that even if Neuralink can prove its device is safe in humans, it would still take several years, potentially more than a decade, for the startup to secure commercial use clearance.
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