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A tweet from Neuralink states that they have received the FDA’s approval to launch their first-in-human clinical study.
Prof Anne Vanhoestenberghe, Professor of Active Implantable Medical Devices from King’s College London, said:
“There are already examples of electrical devices such as the deep brain stimulator (DBS), that are regularly implanted in the brain by neurosurgeons. There are also electrode grid arrays used in patients with epilepsy, but there are no implantable recording devices that are functionally reliable long-term in humans.
“Whilst implanting devices in the brain is routinely done clinically for DBS, and whilst there are already a few humans with high density brain interfaces, we are a long way from high density brain interfaces used chronically. There are many technological and clinical challenges to overcome, including engineering and implanting devices whose signal quality does not drop over time.”
On the ethics:
“The field has been discussing ethical use of brain interfaces for decades. We must ensure that these devices are used for the benefits of patients and the community, with equity of access. There are really important discussions to have about ableism, about how the devices will be used and any potential for malicious use. These may feel quite remote concepts, whilst questions on data safety and privacy are much more widely understood. Finally, and most importantly, whenever a new technology is used for the first time in humans, we consider the risks to the first patients. Whilst we are driven by the potential benefits to the community, these devices are not zero-risk. Potential participants to these studies undergo hours of evaluation, including meetings with psychologists to evaluate their suitability.”
On Neuralink:
“With or without Neuralink, the work in this field is tremendously exciting, despite issues such as the slow drop in data quality and the fact that the electronics equipment is not always implantable. Yet, it will be many years before this technology has matured enough to benefit patients, and when devices become clinically available, how costly will this tech be?”
“We must remember that neurotechnology should, and can, address global problems, with considerations such as access, affordability and sustainability. When engineers work closely with clinicians, they create devices that address clinical needs, delivering benefits to patients, to their families, to their communities.”
Prof Michael Platt, Director, Wharton Neuroscience Initiative and James S. Riepe University Professor of Marketing, Psychology, and Neuroscience, University of Pennsylvania, said:
“There’s really nothing new here with Neuralink, other than advances in the number of electrodes, onboard processing, and the “sewing machine” that precisely implants the electrodes. Utah arrays (https://www.medicaldesignandoutsourcing.com/utah-array-brain-computer-interface-blackrock-neurotech/#:~:text=Studied%20in%20humans%20since%202004,BCI%20applications%20for%20movement%20disorders) are FDA approved and have been used in human studies since 2004. The new tech is pretty awesome, and may enable even greater therapeutic benefits, especially when combined with advanced machine learning and artificial intelligence.”
Prof Tara Spires-Jones, President of the British Neuroscience Association, UK Dementia Research Institute Group Leader, and Deputy Director of the Centre for Discovery Brain Sciences at the University of Edinburgh says:
“The idea of brain-machine interfaces like those proposed by Neuralink is coming closer than ever to reality as seen this week in the exciting clinical trial in which scientists implanted a brain-spine interface to help a person with paralysis walk. However, these interfaces require invasive neurosurgery and are still in experimental stages thus it will likely be many years before they are commonly available. Even if it is confirmed that the FDA has approved the Neuralink trial, this will still be a trial that will take years to complete.”
Dr Dean Burnett, Honorary Research Associate, Cardiff University, said:
“Neuralink is NOT new technology. Chips implanted in the brain to allow humans to directly interface with and control computer programmes has been around for decades now. As far as I can see, Musk’s original contribution is to roll it out for the mass market, where it’s usually been reserved for people who’ve been paralysed or injured in some way, and this is a method of restoring some autonomy to them.
“I am unsure as to the FDA approval for testing story, because there’s been a lots questions raised around Neuralink’s experimental animal subjects, and one would hope such matters would at least be dealt with before humans are subjected to similar processes.
“Even if Neuralink were to become approved and available to the general market, it would logically mean everyone who wants to partake in it has to undergo literal brain surgery. Where are all the medical experts and facilities going to come from to allow this? And in a post-pandemic era when medical infrastructure is already stretched to/beyond breaking point, a company poaching all the most highly qualified surgeons to work on non-essential procedures purely for ‘convenience’, this seems like a very damaging move.
“Alternatively, maybe Neuralink expects to have chips inserted in people’s brain by less-qualified individuals with minimal training. That’s just as bad, if not worse, for a whole other host of reasons.
“ I remain sceptical that this technology, even if it offers all that’s promised, will ever be as widespread or popular as Musk hopes. Because ultimately, it is a case of people undergoing expensive and risky medical procedures, in order to do something that they can do very easily, with minimum effort and zero cost, with their own hands. It may be ‘cool’ to just think of opening a programme and it happens, or getting Alexa to do something with just a thought, but will that be reward enough for such a drastic investment? It’s a big ask.
“There’s also the matter that all brains are different, everyone’s develops, down to the structural level, in a manner that is shaped by life experiences, which are obviously unique to everyone. Mass production of something like this would require a one-size-fits-all approach, to a significant degree. Having a bespoke procedure each time would be hugely costly and limiting, in terms of profits. Ergo, I can easily envisage a scenario where Neuralink chips don’t work very well for many customers, which is obviously a very harmful outcome for something like this.”
Tweet from Neuralink – https://twitter.com/neuralink/status/1661857379460468736
Declared interests
Prof Anne Vanhoestenberghe: “no relevant declarations of interest.”
Dr Dean Burnett: “I’ve no COI with Neuralink.”
Prof Michael Platt is a scientific advisory board member, consultant, and/or co-founder of Blue Horizons International, NeuroFlow, Amplio, Cogwear Technologies, Burgeon Labs, and Glassview, and receives research funding from AIIR Consulting, the SEB Group, Mars Inc, Slalom Inc, the Lefkort Family Research Foundation, Sisu Capital, and Benjamin Franklin Technology Partners.
Prof Tara Spires-Jones: “I have no conflicts with Neuralink.”
For all other experts, no reply to our request for DOIs was received.