Elon Musk’s Neuralink knew its brain implant was likely to malfunction in its first human patient but performed the surgery anyway, a new report says.
In January, the company implanted a brain chip in its first patient, Noland Arbaugh. He is paralyzed from the shoulders down due to a diving accident in 2016.
But during the operation, Mr. Arbaugh suffered a life-threatening condition that later resulted in “a number of threads being withdrawn from the brain,” Neuralink said in a blog update last week.
Now, a Reuters report citing “five people familiar with the matter” says this animal testing problem “has been known about for years.”
Still, the company felt the risk was low enough that a redesign wasn’t warranted, the sources added.
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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The company announced last week that the implant’s tiny wires, thinner than a human hair, were withdrawn from a patient’s brain in its first human trial, resulting in fewer electrodes that could measure brain signals.
The signals are translated into actions, such as moving a mouse pointer 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 that included changing its algorithm to make it more sensitive.
The sources did not want to be named, citing confidentiality agreements they had 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 had reported animal testing results as part of its application to begin human trials, one of the people said.
The FDA declined to comment on whether it was aware of the issue or its possible significance.
The agency told Reuters it would continue to monitor the safety of patients participating in the Neuralink trial.
If Neuralink were to continue trials without a redesign, it could face challenges if more cables fall out and algorithm optimization proves insufficient, one of the sources said.
But redesigning the threads comes with its own risks.
Anchoring it in the brain, for example, could lead to damage to brain tissue if the threads come loose or the company has to remove the device, two of the sources said.
The company tried to design the stitches to be seamlessly removed so that the implant could be updated over time as technology improved, current and former employees say.
Last week’s post from Neuralink made no mention of negative effects on Arbaugh’s health, nor did it disclose how many of the device’s 64 threads have become detached or stopped collecting brain data.
According to blog posts and videos from the company, the device has so far allowed Arbaugh to play video games, surf the Internet and move a computer cursor on his laptop by thinking alone.
Neuralink says that shortly after the surgery, Arbaugh broke the world record for the speed at which he can control a cursor using just his mind.
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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 in animal testing and for problems to arise in animal testing and clinical testing.
Experts who have studied brain implants say the thread movement problem can be difficult to solve, in part because of the mechanisms by which the brain moves within the skull.
Robert Gaunt, a neuroengineer at the University of Pittsburgh, described the movement of the wires so soon after surgery as disappointing but said it was not unforeseen.
“The immediate days, weeks and months after such an implant are probably the most vulnerable times,” he said.
In 2022, the FDA initially rejected Neuralink’s application to begin human trials, citing safety concerns about the threads, as Reuters exclusively reported last year.
Neuralink conducted additional animal testing to address these concerns, and the FDA gave the company approval to begin human testing last year.
The company found that a subset of pigs implanted with the device developed a type of inflammation in the brain called granulomas, which raised concerns among Neuralink researchers, according to three sources familiar with the matter and records seen by Reuters. that the threads could be the cause.
Granulomas are an inflammatory tissue reaction that can form around a foreign body or infection.
In at least one case, a pig developed severe disease.
Company documents reviewed by Reuters show the pig developed a fever and convulsed severely after the operation.
Neuralink researchers didn’t realize the extent of the problem until they examined the pig’s brain postmortem.
Within Neuralink, researchers discussed how to fix the problem and launched 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 threads attached to it were not to blame, one of the sources said.