Neuralink, the brain-implant startup led by Elon Musk, has announced that an independent review board has granted approval to initiate the recruitment of participants for its inaugural human trial. The company is actively seeking individuals with paralysis to take part in a six-year research study aimed at testing its groundbreaking device.
The study is open to individuals who are experiencing paralysis resulting from cervical spinal cord injury or amyotrophic lateral sclerosis (ALS). While the exact number of participants in the trial was not disclosed, the research is expected to span approximately six years until its conclusion.
Neuralink is among a group of companies working on a brain-computer interface (BCI) capable of capturing and processing brain signals. However, the extravagant marketing efforts of its billionaire CEO, which have included commitments to create a comprehensive brain-computer system to augment human capabilities alongside artificial intelligence, have prompted doubt and ethical inquiries among neuroscientists and other professionals.
In this study, a robot will be utilized to perform the surgical placement of a brain-computer interface (BCI) implant within the brain area responsible for controlling the intention to initiate movement. Neuralink’s primary objective is to empower individuals to operate a computer cursor or keyboard solely through their thoughts.
Neuralink had initially sought approval to implant its device in ten patients but entered negotiations with the U.S. Food and Drug Administration (FDA) to reduce this number following safety concerns raised by the agency, as reported by both current and former employees. The final count of patients approved by the FDA remains undisclosed.
During the previous year, Neuralink’s request for expedited human trials was declined by the Food and Drug Administration (FDA). However, in May of this year, the FDA granted Neuralink an investigational device exemption (IDE), which permits the use of their device in clinical studies.
The company’s announcement follows the receipt of regulatory approval for a trial, marking several months of progress. However, prior animal testing has come under intense scrutiny, with reports suggesting that these trials resulted in undue suffering. Former employees have described these tests as problematic, with one instance reported where the device was incorrectly implanted in pigs, necessitating their euthanasia.
These allegations have prompted a series of investigations, including inquiries by the Department of Agriculture into potential animal abuse and the Department of Transportation regarding the improper handling of biohazardous materials across state borders.
The company has not provided immediate responses to questions regarding the trial’s timing, location, or participant count. If the device proves safe in this trial, it may still take many years before it receives clearance for use beyond the trial phase.
Elon Musk has ambitious plans for Neuralink, envisioning a future where the company’s chip devices can be swiftly implanted through surgery to address various conditions such as obesity, autism, depression, and schizophrenia.
(Source: Mariam Sunny | Pooja Desai | Reuters | Maanvi Singh | The Guardian)
