Neuralink, the Elon Musk-owned business, had been aware of the problem for years prior to its revelation last week that the minuscule wires within the brain of its first patient had come loose, according to five individuals acquainted with the situation.
According to three of the people, the business was aware that the wires may retract and take the delicate electrodes that interpret brain impulses with them because of animal research it had done prior to receiving U.S. permission last year. According to the sources, Neuralink determined that there was not enough danger to justify a redesign.
Neuralink is investigating an implant that might aid people with spinal cord injuries by enabling paralysed patients to operate digital gadgets just by thinking.
In its first human study, the implant's minuscule wires—thinner than a human hair—retracted from a patient's brain, according to the firm, leaving fewer electrodes that could detect brain activity.
The signals are converted into commands, like dragging the mouse pointer across a computer screen. The business said that by making adjustments, including changing the algorithm to be more sensitive, it was able to restore the implant's capacity to track its patient's brain impulses.
Citing confidentiality agreements they had signed with the corporation, the sources refused to be named. Calls and emails for response from Neuralink and its executives were not answered.
According to one of the sources, the business submitted the findings of its animal research as part of its application to start human trials, so the FDA in the United States was aware of the possible problem with the wires.
Regarding whether it was aware of the problem or its potential importance, the FDA declined to comment. The organisation assured Reuters that it will keep an eye on the security of patients involved in Neuralink's research.
According to one of the insiders, if Neuralink were to carry out the trials without a redesign, it may run into problems if additional wires break out and its algorithmic adjustment proves insufficient.
However, there are hazards associated with redesigning the threads. According to two of the insiders, if the corporation decides to remove the device or if the threads loosen, anchoring them in the brain might cause harm to brain tissue.
According to current and former employees, the corporation designed the threads to be easily removed so that the implant could be upgraded as technology advanced.
Neuralink placed the gadget in the brain of Noland Arbaugh, its first patient, in January. Arbaugh had a diving accident in 2016 that left him paralysed from the shoulders down.
Neuralink stated in a blog post last week that "a number of threads retracted from the brain" in the weeks following the procedure.
The post did not reveal how many of the 64 threads on the device disconnected or ceased to gather brain data, nor did it discuss any negative impacts on Arbaugh's health.
According to corporate blog postings and videos, Arbaugh has been able to use the gadget to play video games, access the internet, and control the computer cursor on his laptop only by thinking. According to Neuralink, shortly after the procedure, Arbaugh broke the world record for the fastest mental cursor control.
According to independent experts and people who have worked at Neuralink and other medical device firms, it is typical for medical device companies to troubleshoot multiple designs during animal trials and for difficulties to occur throughout animal and clinical testing.
Experts who have researched brain implants believe that because of the way the brain moves inside the skull, it can be challenging to find a solution when it comes to thread movement.
The movement of the wires so soon after the operation was disheartening, but Robert Gaunt, a brain engineer at the University of Pittsburgh, noted that it was not unexpected. "The most vulnerable period is probably in the early days, weeks, or months following an implant like this," he stated.
According to an exclusive Reuters story from last year, the FDA first denied Neuralink's request to start human trials in 2022 and expressed worries about the threads' safety.
To allay such fears, Neuralink carried out further animal testing, and the FDA allowed the business to start conducting human trials last year.
Three persons familiar with the situation and documents obtained by Reuters claim that the business discovered that a portion of pigs implanted with its device had granulomas, a form of inflammation in the brain that raised suspicions among Neuralink's researchers that the threads may be the cause.
Granulomas are a type of inflammatory tissue reaction that can develop in the vicinity of an infection or foreign item.
A pig with a severe case of the disease was seen in at least one case. After surgery, the pig started to heave and developed a temperature, according to company data that Reuters examined. The scope of the issue was not understood by Neuralink's researchers until they examined the pig's brain after it had died.
According to the people with knowledge of the events, experts at Neuralink discussed how to fix the problem and started a months-long inquiry.
According to one of the individuals, the business ultimately came to the conclusion that neither the device nor the associated threads were to blame for the granulomas despite its inability to identify their origin.
(Source:www.reuters.com)
According to three of the people, the business was aware that the wires may retract and take the delicate electrodes that interpret brain impulses with them because of animal research it had done prior to receiving U.S. permission last year. According to the sources, Neuralink determined that there was not enough danger to justify a redesign.
Neuralink is investigating an implant that might aid people with spinal cord injuries by enabling paralysed patients to operate digital gadgets just by thinking.
In its first human study, the implant's minuscule wires—thinner than a human hair—retracted from a patient's brain, according to the firm, leaving fewer electrodes that could detect brain activity.
The signals are converted into commands, like dragging the mouse pointer across a computer screen. The business said that by making adjustments, including changing the algorithm to be more sensitive, it was able to restore the implant's capacity to track its patient's brain impulses.
Citing confidentiality agreements they had signed with the corporation, the sources refused to be named. Calls and emails for response from Neuralink and its executives were not answered.
According to one of the sources, the business submitted the findings of its animal research as part of its application to start human trials, so the FDA in the United States was aware of the possible problem with the wires.
Regarding whether it was aware of the problem or its potential importance, the FDA declined to comment. The organisation assured Reuters that it will keep an eye on the security of patients involved in Neuralink's research.
According to one of the insiders, if Neuralink were to carry out the trials without a redesign, it may run into problems if additional wires break out and its algorithmic adjustment proves insufficient.
However, there are hazards associated with redesigning the threads. According to two of the insiders, if the corporation decides to remove the device or if the threads loosen, anchoring them in the brain might cause harm to brain tissue.
According to current and former employees, the corporation designed the threads to be easily removed so that the implant could be upgraded as technology advanced.
Neuralink placed the gadget in the brain of Noland Arbaugh, its first patient, in January. Arbaugh had a diving accident in 2016 that left him paralysed from the shoulders down.
Neuralink stated in a blog post last week that "a number of threads retracted from the brain" in the weeks following the procedure.
The post did not reveal how many of the 64 threads on the device disconnected or ceased to gather brain data, nor did it discuss any negative impacts on Arbaugh's health.
According to corporate blog postings and videos, Arbaugh has been able to use the gadget to play video games, access the internet, and control the computer cursor on his laptop only by thinking. According to Neuralink, shortly after the procedure, Arbaugh broke the world record for the fastest mental cursor control.
According to independent experts and people who have worked at Neuralink and other medical device firms, it is typical for medical device companies to troubleshoot multiple designs during animal trials and for difficulties to occur throughout animal and clinical testing.
Experts who have researched brain implants believe that because of the way the brain moves inside the skull, it can be challenging to find a solution when it comes to thread movement.
The movement of the wires so soon after the operation was disheartening, but Robert Gaunt, a brain engineer at the University of Pittsburgh, noted that it was not unexpected. "The most vulnerable period is probably in the early days, weeks, or months following an implant like this," he stated.
According to an exclusive Reuters story from last year, the FDA first denied Neuralink's request to start human trials in 2022 and expressed worries about the threads' safety.
To allay such fears, Neuralink carried out further animal testing, and the FDA allowed the business to start conducting human trials last year.
Three persons familiar with the situation and documents obtained by Reuters claim that the business discovered that a portion of pigs implanted with its device had granulomas, a form of inflammation in the brain that raised suspicions among Neuralink's researchers that the threads may be the cause.
Granulomas are a type of inflammatory tissue reaction that can develop in the vicinity of an infection or foreign item.
A pig with a severe case of the disease was seen in at least one case. After surgery, the pig started to heave and developed a temperature, according to company data that Reuters examined. The scope of the issue was not understood by Neuralink's researchers until they examined the pig's brain after it had died.
According to the people with knowledge of the events, experts at Neuralink discussed how to fix the problem and started a months-long inquiry.
According to one of the individuals, the business ultimately came to the conclusion that neither the device nor the associated threads were to blame for the granulomas despite its inability to identify their origin.
(Source:www.reuters.com)
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