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Neuralink Gets Approval to Begin Human Implant Trials

Elon Musk's brain implant company is now seeking test subjects for its experimental brain chip after receiving approval to begin human tests. The FDA cleared the testing in May.

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(TNS) — Neuralink, Elon Musk's brain implant company, is seeking test subjects for its experimental brain chip after receiving approval to begin human tests.

The company, which has offices in Austin, said Tuesday people with paralysis may apply to take part in a six-year study of its technology to allow people to control computer interfaces with their brains.

"The initial goal," Neuralink said, "is to grant people the ability to control a computer cursor or keyboard using their thoughts alone."

The California-based company said Tuesday it received approval from an independent review board to begin seeking subjects for the research. People with quadriplegia due to cervical spinal cord injuries or amyotrophic lateral sclerosis, which is also known as ALS or Lou Gehrig's disease, may qualify for the study it calls PRIME — shorthand for Precise Robotically Implanted Brain-Computer Interface.

Neuralink in May was approved by the U.S. Food and Drug Administration to begin human trials. Last month, it said it raised $280 million and was hiring in preparation for the work.

In the study, the company's surgical robot will be used to cut coin-sized openings in subject's heads and insert hair-thin threads of 1,024 electrodes into the motor cortex of the brain that controls movement intention before placing the round device in the opening.

It was unclear when and where Neuralink would perform the procedures. It said only that it had received permission from its "first hospital site" to begin recruiting individuals for the study.

Neuralink did not respond to emailed questions.

In a statement, it said it is seeking individuals who are 22 or older and have a caregiver. It estimated the study would run six years, with regular at-home and in-person clinic visits, research participation sessions and long-term follow-ups.

Musk, the owner of social media platform X, formerly Twitter, who also oversees Tesla Inc., SpaceX and The Boring Co. operations in Texas, began moving a Neuralink location into Austin last year. As of Tuesday, the company's website included 20 openings for full-time jobs and internships there, including veterinary pathologist and several surgery, software and mechanical engineers.

OTHER AREA PROJECTS


Neuralink, founded in 2016, is part of a growing number of academic groups and companies studying and developing brain-computer interfaces in the South Texas region.

For years, students and professors at the University of Texas at San Antonio have used grants from the federal government and Defense Department to develop brain-computer interface methods to study the brain and ways to help people reduce how often they stutter, for example.

Paradromics Inc., an Austin-based startup founded in 2015, announced in May that it had raised $33 million to pursue its development of devices that could help launch its first human trial in 2024. The company aims to help people with ALS, spinal cord injuries and strokes to communicate.

Musk has described how he hopes to use Neuralink implant technology to aid people with severe disabilities and eventually bring humans to a state of "symbiosis" with artificial intelligence. He appears to believe the human-machine merger will help humans to keep on pace with the rapidly advancing pace of AI technologies.

But Neuralink has so far only tested its implant technology on animals. In April 2021, the company released a video showing a 9-year-old macaque named Pager with two implanted devices able to play a videogame called Pong using only his brain.

BACKLASH


Neuralink has faced backlash for its studies on primates.

In February 2022, a medical nonprofit called the Physicians Committee for Responsible Medicine filed a complaint with the U.S. Department of Agriculture alleging the company had performed "invasive and deadly brain experiments" on macaques. The nonprofit claimed that the University of California, Davis, had received more than $1.4 million from the company to conduct the studies.

In response, Neuralink last year replied on X: "Animals at Neuralink are respected and honored by our team. Without proper context, information from medical records and study data can be misleading."

The company also said in a blog post that, "Two animals were euthanized at planned end dates to gather important histological data, and six animals were euthanized at the medical advice of the veterinary staff at UC Davis."

In August 2022, the nonprofit of physicians protested the company's research outside of Austin City Hall and said they paid for advertisements on Capital Metro buses that run in the area. The next month, the nonprofit accused the University of California, Davis, of possessing 371 photos of abused monkeys used in Neuralink studies.

Such complaints have led to federal investigations.

In December, the USDA's Inspector General opened an investigation into Neuralink focusing on potential violations of the Animal Welfare Act, after internal staff apparently complained about how research caused monkeys to suffer and die.

In February, the U.S. Department of Transportation began investigating Neuralink after the nonprofit group of physicians raised concerns over its potential illegal transporting of pathogen-laced devices used in monkeys.

©2023 the San Antonio Express-News, Distributed by Tribune Content Agency, LLC.