While some experts are ‘cautiously excited’ about the start of the human trial, Nature reports some neuroscientists have frustrations about the lack of detailed information and no confirmations that the study has begun besides a tweet from the company’s owner entrepreneur Elon Musk.
“What I hope to see is that they can demonstrate that it is safe. And that it is effective at measuring brain signals — short term, but, most importantly, long term,” Mariska Vansteensel, a neuroscientist at University Medical Centre Utrecht in the Netherlands and president of the international BCI Society, told the Nature Journal.
Concerns with transparency
The main source of information on the human trial of the BCI technology is a study brochure that encouraged people to participate in the study. There are no details explaining where the implantations are performed or what the trial outcome will assess. However, the brochure does mention that volunteers will be followed for five years and that the trial will assess the device’s functionality, with study participants using the implant twice a week to control a computer and provide feedback on the experience while using the BCI.
Additionally, the trial is not registered on the U.S. National Institutes of Health online registry of clinical trials, ClinicalTrials.gov. The website is publicly accessible to anyone and is intended to provide comprehensive information about clinical studies to patients, healthcare professionals, researchers and the general public. It also provides transparency, participant recruitment, regulatory compliance and research collaboration.
Many universities require registration on ClinicalTrials.gov as researchers must register a trial and its protocol in a public repository before study participants can be enrolled in the trial, Nature Journal reports. The registration also ensures that the study aligns with ethical principles to protect volunteers for clinical trials.
Neuralink first-in-human implant and regulatory history
Musk announced on X (formerly Twitter) that the first-in-human implant of its BCI technology took place on January 28.
“The first human received an implant from Neuralink yesterday and is recovering well,” Musk posted. “Initial results show promising neuron spike detection.”
The company won a regulatory nod in May for a first-in-human implant, and in September, it opened up recruitment for its clinical trial. Musk also announced in August that Neuralink brought in $280 million, and the company added a further $43 million in November.
Remotely rechargeable, the implant goes along with electrode-laced threads that go further into the brain. Neuralink also has an R1 robot to be programmed to implant the BCI system while avoiding vasculature.
The company designed its system to enable users to control a computer or mobile device anywhere they go.
More recent news on Neuralink
Despite the positive updates on in-human implants, Neuralink has been in the news for the wrong reasons of late as well.
Reuters reported about a year ago that the U.S. government would look into Neuralink after reports of errors resulting in repeated experiments, with more animals losing their lives as a result.
Now, following a letter from U.S. lawmakers urging the SEC to look into Neuralink’s monkey deaths (reported by Wired in November), Musk denied the allegations of gruesome deaths as a result of the BCI implant.
Business Insider reported that, at The New York Times’ Dealbook conference, Musk said the test monkeys live in “monkey paradise.” He went on to say that the implant set for first-in-human testing never directly caused the death of a monkey.
In January, Neuralink was reportedly fined for violating rules related to the movement of hazardous materials.