Elon Musk’s Neuralink knew its brain implant was unlikely to function properly in its first human patient, but went ahead with the surgery anyway, a new report claims.
In January, the company implanted a brain chip in its first patient, Noland Arbaugh, who is paralyzed from the shoulders down following a 2016 diving accident.
But during the surgery, Mr. Arbaugh developed a life-threatening condition that later caused “a number of wires to be withdrawn from the brain,” Neuralink said in a blog update last week.
Now a Reuters report citing “five people familiar with the matter” claims the issue has been “known for years” through animal testing.
Still, the company deemed the risk low enough not to merit a redesign, the sources said.
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Neuralink is testing its implant to give paralyzed patients the ability to use digital devices by thinking alone – a prospect that could help people with spinal cord injuries.
The company said last week that the implant’s tiny wires, which are thinner than a human hair, were withdrawn from a patient’s brain during the first human trial, resulting in fewer electrodes that could measure brain signals.
The signals are translated into actions, such as moving a mouse cursor on a computer screen.
The company said it managed to restore the implant’s ability to monitor its patient’s brain signals by making changes, including adjusting the algorithm to be more sensitive.
The sources declined to be identified, citing confidentiality agreements they signed with the company.
Neuralink and its executives did not respond to calls and emails seeking comment.
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The U.S. Food and Drug Administration was aware of the potential problem with the wires because the company shared animal test results as part of its application to start human trials, one of the people said.
The FDA declined to comment on whether it was aware of the issue or its potential significance.
The agency told Reuters it would continue to monitor the safety of patients enrolled in Neuralink’s study.
If Neuralink were to continue testing without a redesign, it could face challenges if more threads fail and tweaks to the algorithm prove insufficient, one of the sources said.
But redesigning the wires comes with its own risks.
For example, anchoring it in the brain could lead to damage to brain tissue if the wires become loose or if the company has to remove the device, two sources said.
The company has tried to design the wires so that their removal is seamless, so the implant can be updated over time as technology improves, current and former employees say.
Last week’s Neuralink post made no mention of any adverse health effects for Arbaugh and did not reveal how many of the device’s 64 wires withdrew or stopped collecting brain data.
So far, the device has allowed Arbaugh to play video games, surf the Internet and move a computer cursor on his laptop just by thinking, according to company blog posts and videos.
Neuralink says that shortly after the surgery, Arbaugh surpassed the world record for the speed at which he could control a cursor with thoughts alone.
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According to outside researchers and sources who have worked at Neuralink and other medical device companies, it is common for medical device companies to troubleshoot different designs during animal testing and for problems to arise during animal testing and clinical testing.
Specialists who have studied brain implants say the moving wires problem is difficult to solve, partly because of the mechanics of how the brain moves in the skull.
Robert Gaunt, a neural engineer at the University of Pittsburgh, described the movement of the wires so soon after surgery as disappointing, but said it was not unforeseen.
“In the first days, weeks, months after an implant like this, this is probably the most vulnerable time,” he said.
In 2022, the FDA initially rejected Neuralink’s application to begin human trials, citing concerns about the wires’ safety, Reuters exclusively reported last year.
Neuralink conducted additional animal testing to address these concerns, and the FDA cleared the company last year to begin testing on humans.
The company found that some of the pigs implanted with the device developed a type of inflammation in the brain called granulomas. This raised concerns among Neuralink researchers that the wires could be the cause, according to three sources familiar with the matter and data seen by Reuters.
Granulomas are an inflammatory reaction of the tissue that can form around a foreign object or infection.
In at least one case, a pig developed a severe case of the condition.
Company records reviewed by Reuters show the pig developed a fever and was panting after the operation.
Neuralink researchers only recognized the extent of the problem after examining the pig’s brain post-mortem.
Inside Neuralink, researchers debated how to fix the problem and began a months-long investigation, sources familiar with the events said.
Ultimately, the company was unable to determine the cause of the granulomas, but concluded that the device and the wires attached to it were not to blame, one of the sources said.