Elon Musk’s brain-chip startup, Neuralink, has received approval to begin its first human trial. Patients with cervical spinal cord injuries or amyotrophic lateral sclerosis (ALS) paralysis will be the focus of the clinical study.
According to Nueralink, the Food and Drug Administration (FDA) gave the startup a go-ahead on September 19 to start recruiting humans for the trial.
“We are happy to announce that we’ve received approval from the reviewing independent institutional review board and our first hospital site to begin recruitment for our first-in-human clinical trial. The PRIME Study (short for Precise Robotically Implanted Brain-Computer Interface)—a groundbreaking investigational medical device trial for our fully-implantable, wireless brain-computer interface (BCI)—aims to evaluate the safety of our implant (N1) and surgical robot (R1) and assess the initial functionality of our BCI for enabling people with paralysis to control external devices with their thoughts,” Nueralink stated.
According to founder Musk, human patients will soon get the device, which they hope will restore full body movements in paralysed people.
“The first human patient will soon receive a Neuralink device. This ultimately has the potential to restore full-body movement. In the long term, Neuralink hopes to play a role in AI risk reduction and civilizational risk reduction by improving human-to-AI (and human-to-human) bandwidth by several orders of magnitude,” Musk said.
During the study, the R1 robot will be used 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 cosmetically invisible and is intended to record and transmit brain signals wirelessly to an app that decodes movement intention.
The World Health Organisation states that every year, around the world, between 250 000 and 500 000 people suffer a spinal cord injury (SCI) and more than 200,000 people around the world are living with ALS, of which the number is expected to rise to 376,674 in 2040.
Many are hopeful that if Neuralink’s BCI is successful in human trials, it could drastically change the lives of people with quadriplegia and other neurological disorders.
However, Musk’s long-term vision for Neuralink goes beyond the treatment of paralysis.
The founder has ambitious plans that extend to rapid surgical insertion of chip devices to manage a range of conditions, from obesity and autism to depression and schizophrenia.
Those with quadriplegia due to cervical spinal cord injury or ALS are eligible for this trial, and applications are being accepted.