“Can I please have snacks,” a monkey called Sake typed with its mind on the computer screen. And then it got some grapes as it wished.
Fluorescent dye imaging of the surface of the brain. Courtesy of Neuralink
Would you be part of a clinical trial that involves implanting electrodes and super thin wires into your brain and having a part of the skull removed to insert a computer the size of a coin? As intimidating as it sounds, Neuralink has already received thousands of applications from potential volunteers, according to a report by Bloomberg.
In a lesser-known Brain-Computer Interface(BCI) experiment conducted by Brown University in 2002, a monkey succeeded in using its mind to move the mouse on a screen. Twenty years later in December 2022, Elon Musk and his Neuralink let a monkey named Sake demonstrate “telepathic typing” during Neuralink’s show-and-tell event. Less than six months later, Neuralink announced winning the US Food and Drug Administration (FDA) approval for human trials. Now, the company is approved to recruit human volunteers for brain-implant trials.
In September, the company sought out people with paralysis to test its experimental device in a six-year study. An ideal candidate would be an adult under the age of 40 whose four limbs are paralyzed.
We’re excited to announce that recruitment is open for our first-in-human clinical trial!
If you have quadriplegia due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS), you may qualify. Learn more about our trial by visiting our recent blog post.…
— Neuralink (@neuralink) September 19, 2023
To put it in simple words, a BCI is a computer-based system that collects brain signals, analyzes them, and translates them into commands that can be sent to an output device to act. Among the three BCI types: invasive BCIs, partially-invasive BCIs, and non-invasive BCIs, Musk chose to conquer the invasive BCI, the toughest one that involved surgical implantation of a device into the skull of the user. This technology, according to Musk, will let the paralyzed walk, the blind see, and eventually turn humans into cyborgs.
The Neuralink N1 implant. Photograph: Neuralink
Following the half-stunning, half-intimidating demonstration of Sake, Musk announced that Neuralink would begin human trials and implant chips in human brains in six months. At the time, Musk seemed to be asking for the moon with this audacious claim, since the most urgent task for Neuralink was passing the FDA approval. And FDA has been rigid with clinical trials that involve human brains and for good reasons.
While scholars scornfully suggest that Musk’s understanding of BCI is far behind academia’s, this incredible demonstration of Sake still made a considerable noise, reminding the public of sci-fi movies like Matrix, which illustrated a brain in a vat (BIV) world that seems to approach us at a faster pace.
That future is still out of reach. Challenged by technical and ethical difficulties, the invasive BCI sees more obstacles than successful application.
The academic world has not even developed a comprehensive understanding of our brains. Before collecting brain signals with computer-based tools, there are already too many restrictions with implant surgery, the rejection of the human body, and the hardware materials required for the surgery.
Society’s acceptance and the ethical questions that arise are other challenges for Musk’s ambitious project. Neuro-rights, the right to personal identity, have been defended consistently by the scientific community. Neuralink’s approach, without a rigorous supervision system, would be modifying human nature. Data privacy would also be in severe danger once the human brain is open for data collection.
The prospect of aiding patients with ALS, Alzheimer, paralysis, and other diseases to live a normal life is the most positive application in the next five to ten years recognized by academia.
In 2019, Neuralink filed a petition with the FDA and failed. Only until July 2021 did the FDA approve the first invasive BCI human trial for Neuralink’s biggest competitor, Synchron. In March 2022, Synchron announced that four ALS patients in Australia implanted with their system, Stentrode, have already participated in a yearlong monitoring project where they could complete daily tasks like sending emails and online shopping through computers. When Synchron already started patient enrollment for BCI studies in March this year, Neuralink was rejected again by the FDA, according to a report by Reuters.
The report states that FDA’s major safety concerns regarding the device include the lithium battery, the possibility of the implant’s wires migrating to other brain areas, and the challenges surrounding its removal without causing damage to brain tissue.
Synchron and Neuralink adopted different technologies with their implants. Neuralink’s surgical robot implants the chip accurately into the brain with a tiny needle to carefully place the electrodes. “It’s like replacing a piece of the skull with a smartwatch,” says Musk. On the other hand, Synchron’s Stentrode gets implanted in the brain through a vein in the neck using a minimally invasive procedure.
Synchron might be ahead of Neuralink for now, but Neuralink is in no shortage of abundant resources and funds. The $130 million raised by Synchron is far behind the $363 million raised by Neuralink.
While we wade the river of ethical constraints, we do need to build bridges to the future.
This story is updated from a previous version on September 20, 2023.
