Neuralink, that of Elon Musk brain-computer interface startup, is looking for human volunteers to participate in its first clinical trial. In a September 19 announcementthe company says its PRIME (Precise Robotically Implanted Brain-Computer Interface) study will test a “revolutionary experimental medical device” on test subjects already suffering from quadriplegia due to amyotrophic lateral sclerosis (ALS) or cervical spinal cord injury.
Once implanted via a surgical robot using ultra-thin and flexible wiring, the preliminary BCI device would wirelessly transmit data to an external computer to decode patients’ movement intentions. Neuralink’s ultimate goal for the (PRIME) study is to grant its volunteers the ability to wirelessly control a computer mouse or keyboard with their brain.
The company faced numerous setbacks before final approval of the study by an independent institutional review board and its first hospital site. Despite Musk’s promises from 2019 regarding the imminent arrival of the technology, Neuralink would only have searched first FDA approval for approval of human clinical testing in 2022. The regulatory body refused Neuralink’s request at the time, citing concerns about possible brain damage resulting from faulty wiring and overheating of BCI devices, as well as complications regarding its removal. In May, the FDA finally granted Neuralink an exemption relating to investigative devices (IDE).
But even before its requests for clinical trials on humans, Neuralink repeatedly aroused the anger of the authorities. critics and watchdogs regarding its treatment of test animals. In December 2022 Reuters presentation, “internal staff complaints” regarding animal welfare issues described “hacking work” procedures that resulted in the deaths of more than 1,500 test subjects since 2018. The report also found that the employees’ accounts prompted the U.S. Department of Agriculture’s inspector general to launch an investigation into the matter. Since then, the USDA investigation received its own share of criticism on prejudices and conflicts of interest.
Neuralink has demonstrated its success so far BCI integration with ratsas well as shared images of a macaque monkey playing Pong via a wired brain implant prototype. Meanwhile, similar BCI devices are in different stages of development. for years— some of which are already meeting and exceeding the objectives of Neuralink’s PRIME study. Earlier this year, researchers at Stanford University devices demonstrated who successfully translated an ALS patient’s thoughts into words to facilitate communication. Meanwhile, another company backed by Jeff Bezos and Bill Gates announced in February 2023 that its researchers successfully implanted a “neuroprosthesis” device in four human subjects.
During a public presentation of Neuralink at December 2022Musk expressed hope that human trials would begin within six months.