Elon Musk’s Neuralink , the brain-implant startup, has announced that it has received approval from an independent review board to initiate the recruitment of patients for its inaugural human trial. This marks a significant step forward in the company’s quest to develop a brain-computer interface (BCI). In a study spanning six years, Neuralink intends to collaborate with individuals suffering from paralysis to assess the efficacy of its experimental device.
While numerous companies are pursuing the development of BCIs for the collection and analysis of brain signals, Neuralink’s high-profile CEO and his ambitious claims about creating an all-encompassing brain-computer interface to enhance human capabilities have elicited skepticism and raised ethical concerns among neuroscientists and experts in the field.
Food and Drug Administration (FDA)
Notably, last year, the Food and Drug Administration (FDA) declined Neuralink’s request for expedited human trials. However, in May, the FDA granted Neuralink an investigational device exemption (IDE), allowing the use of its device in clinical studies. The agency has not disclosed the specific resolution of its initial concerns.
Neuralink is targeting individuals who have quadriplegia due to either vertical spinal cord injuries or ALS for this human trial.The participants will undergo a surgical procedure in which the BCI will be implanted into the brain’s motor control region using Neuralink’s proprietary robot. The ultimate objective is to enable participants to control a computer cursor or keyboard solely through their thoughts. The study’s primary objectives include assessing the safety and functionality of this groundbreaking technology.
This announcement from Elon musk’s neuralink follows months of regulatory approval preparations. However, the company has faced scrutiny regarding its previous animal testing, with allegations of unnecessary suffering and subpar procedures. Former employees have characterized these tests as “hack jobs.” One troubling incident involved the incorrect placement of the device in pigs, leading to their euthanasia. These allegations prompted investigations by multiple agencies, including the Department of Agriculture, which probed into animal abuse, and the Department of Transportation, which examined mishandling of biohazardous materials across state lines.
As of now, Neuralink has not provided details regarding the timing and location of the upcoming trial or the number of participants it will involve. It’s essential to note that even if the device proves safe for human use, it may take decades before it receives clearance for use outside the confines of clinical trials.