Did Neuralink ignore the risk of an early trial? Problems with brain implants plagued lab before human case

Olga Loiek

Neuralink’s first human implant hit a problem last week, with reports suggesting tiny wires crucial to detecting brain signals became loose. Sources familiar with the matter revealed that this problem has been known to Elon Musk’s company for years.

Three sources familiar with the testing claim that animal tests conducted before last year’s US approval indicated that the implanted wires could retract. This withdrawal could also loosen the delicate electrodes responsible for deciphering brain signals.

According to the sources, Neuralink considers the risk of wire retraction minimal, ignoring findings from animal testing. They claim that the Musk-led neurotechnology company has opted for a redesign. Neuralink’s brain implant is being tested to give paralyzed patients control over digital devices using their thoughts.

This technology holds tremendous promise for people with spinal injuries, as evidenced by the recent success of their first human trial participant, Nolan Arbaugh. This person, a 29-year-old paralyzed patient, reportedly gained control of video games, including “Mario Kart,” using only brain signals.

Balance between functionality and safety

Last week, Neuralink acknowledged a setback in their first human trial. The implant’s ultra-thin wires, similar in width to a human hair, shifted out of position in the patient’s brain.

This incident led to a reduced number of functioning electrodes that are crucial for capturing brain signals. These signals are then translated into actions, allowing users to control functions such as cursor movement on a computer screen.

Despite confidentiality agreements with Neuralink, an anonymous source revealed that the Food and Drug Administration (FDA) was made aware of the potential wire problem during the application process for human trials. This information likely came from the animal test results that Neuralink submitted to the FDA.

Benjamin Rapoport, co-founder of Neuralink, recently left the company due to disagreements over security practices. Maintaining patient safety remains a top priority for the FDA.

While the agency declined to comment on specific details of Neuralink’s investigation, the agency told Reuters it will continue to monitor all participants in Neuralink’s investigation.

The way forward for Neuralink

On the other hand, if Neuralink continues testing without solving the wire loosening issue, they may face problems. In particular, more wires can fail and reduce the effectiveness of the implant.

Neuralink’s current algorithm adjustments may not be sufficient to compensate for the fewer working electrodes. However, redesigning the tiny wires that connect to the brain is also a complex solution.

If they opt for a redesign that anchors the wires more firmly in the brain, it could lead to the loosening of these anchored wires and cause injury to the brain. Beyond that, disabling the device in the future, if necessary, could become more complex and potentially risky, two of the sources said.

Current and former employees claim that Neuralink prioritized easily removing threads for future upgrades. Neuralink implanted its device in its first human patient in January, but a blog update last week revealed that some of the wires withdrew from the brain in the following weeks.

Neuralink’s update acknowledged an outage in the thread, but did not provide details on the amount or impact on patient health. The company’s blog posts and videos only show Arbaugh’s progress.

He has performed impressive feats such as playing video games, surfing the Internet, and even setting a new mind-controlled cursor speed record.

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