Want details on Elon Musk's brain implant trial? You'll have to ask him

 Elon Musk's announcement this week that his startup Neuralink had implanted the first human patient with its experimental brain device generated immediate buzz.

But Musk's statements on his social media platform X raised more questions than they answered about the trial for a risky device that the tech billionaire says could one day help the paralyzed walk, four experts in the brain implant field told Reuters.

Neuralink does not have to divulge even basic details about its trial, including the facility where patients are being implanted with the device and monitored, as well as the number of participants and expected completion date.

That is because the study was approved by the U.S. Food and Drug Administration as a "first in human" or "early feasibility" trial, the four experts said, based on Neuralink's characterizations.

Unlike a standard clinical trial, such studies allow companies to develop a product concept, but are not designed to prove safety or efficacy, the experts said. Early feasibility studies like Neuralink's are exempt from a requirement to post trial details on the U.S. National Institutes of Health's website, ClinicalTrials.gov.

That gives Musk more control over what is known about Neuralink's progress. The experts contacted by Reuters said that is concerning, given Musk's track record of public hyperbole regarding his businesses, from electric vehicle maker Tesla to rocket-builder SpaceX.

"Elon Musk is not about transparency," said Kip Ludwig, former program director for neural engineering at NIH. "He's about doling out pieces of information, often in a misleading fashion."

Neuralink did not respond to Reuters' questions. An FDA spokesperson said any clinical trial participants must be provided with information on the risks, potential benefits and alternatives to a specific study and give informed consent to the testing.

"The FDA will continue to monitor the safety of those enrolled in the study for Neuralink's implant device through required, regular reports," the spokesperson said.

In 2022, the FDA reported approving around 40 early feasibility studies.

https://finance.yahoo.com/news/want-details-elon-musks-brain-110345971.html