Neuralink – After First Successful Implant, What Comes Next?

Neuralink has achieved a big milestone as its billionaire founder, Elon Musk, revealed that the first person to receive the chip is now able to operate a computer mouse by using their thoughts. 

“Progress is good, and the patient seems to have made a full recovery, with no ill effects that we are aware of. The patient is able to move a mouse around the screen by just thinking.”

– Musk, who's also behind X (previously Twitter), Tesla, and SpaceX, in a Spaces event on the social media platform X

This update comes after the company successfully implanted a chip in its first human patient just last month. For this, Neuralink started recruiting in September last year as part of the “PRIME Study,” short for “Precise Robotically Implanted Brain-Computer Interface.” The trial, as per the company, studies the safety of the implant, the surgical robot, and the functionality of the device.

One of Musk's most ambitious projects is Neuralink, a neurotechnology company based in California. It was launched in 2016 and first came to public attention in 2017. It was valued at about $5 billion last year, as per Reuters. The startup's last known fundraising was in 2021, when it raised $205 million in a private fundraising at a close to $2 billion valuation, according to data provider Pitchbook.

This boost in valuation came as US regulators approved the human trial of its brain chip. “This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company noted in a tweet in May 2023 about the US Food and Drug Administration (FDA) approval of in-human clinical study. 

The agency approved the request just a couple of months after denying Neuralink's application to test its brain chips in human patients due to safety concerns. The company has not disclosed any of these details, including its trial application and the FDA's rejection and concerns. However, as a private firm, Musk's Neuralink is not obligated to divulge such information to investors.

With Neuralink, Musk aims to merge human consciousness with AI. As he revealed in a podcast many years ago, the company was “intended to address the existential risk associated with digital superintelligence,” and if you can't beat them, join them, he said.

BCI and Enhancing Human Potential 

At Neuralink, the focus is on developing an implantable brain-computer interface (BCI). BCI provides a communication link between the brain and an external device. It acquires brain signals, analyzes them, and then translates them into commands that are communicated to devices that carry out desired actions. 

The primary objective of BCI is to reinstate functions in people who are affected by neuromuscular disorders. Such disorders affect the sensory and motor nerves connecting the brain and spinal cord to the body. Stroke, cerebral palsy, muscular dystrophy, and amyotrophic lateral sclerosis (ALS) are some examples of neuromuscular disorders.

Based on technology, BCIs can be of two main types: invasive and non-invasive. In Invasive BCI, devices are implanted into the brain for high-quality signals. Non-invasive BCI, meanwhile, involves EEG signals taken by placing electrodes on the scalp. 

BCI technology has been the focus of rapidly growing research and development that is greatly exciting clinicians, scientists, engineers, companies, and the public. This is due to the technology having significant advantages in medical fields, ranging from prevention to detection and diagnosis and rehabilitation and restoration.

BCIs are being experimented with worldwide to improve cognitive performance further. Late last year, researchers from Stanford University and the University of California San Francisco published the findings of their studies in the journal Nature, showing that BCIs have allowed two women with paralysis to speak again with unprecedented speed and accuracy. 

Neuralink, meanwhile, is also creating a device that is the size of a coin and is implanted in the skull surgically with a machine dubbed the R1 with very thin wires going into the brain. The device registers brain activity and then sends it over to a device through a Bluetooth connection.

The fully implantable and cosmetically invisible BCI chip called N1 is hermetically sealed in a biocompatible enclosure and powered by a small battery charged wirelessly from the outside. 

To record neural activity, the N1 implant makes use of 1024 electrodes that are distributed across 64 threads, which are highly flexible and extremely thin in order to minimize damage. Due to being so fine, Neuralink uses a surgical robot as these threads of implant can't be inserted by the human hand. The eight-foot-tall robot has a head containing the optics and sensors of 5 camera systems and the optics for an optical coherence tomography (OCT) system as well as a needle, which is thinner than a human hair, to grasp, insert, and release threads.

Once neural signals are processed, the chip transmits them wirelessly to the Neuralink application, which decodes the data stream into actions and intents.

According to Musk, the company's first product, called Telepathy, would allow people to control their phones or computers “just by thinking.” The company claims that planting the chip in part of the brain that controls motor function would also enable people to overcome neurological disorders. Musk's grand ambitions for Neuralink also involve using the chip to treat conditions like autism and schizophrenia. 

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Growing Interest & Competition in BCI

Neuralink has certainly made a huge feat. However, a human with a BCI controlling a cursor isn't something new. In fact, it was achieved decades ago, in 2004, while non-human primates have been doing it even before that. In 2002, neuroscientist John Donoghue also published a paper showing a monkey playing a video game with its brain, using a rudimentary version of BrainGate, and then tested the system in several more experiments.

A January 2023 study analyzing nearly two decades of safety data from clinical trials on BrainGate technology found a low rate of adverse events from implanted BCIs. It concluded that the technology's potential to restore communication and mobility warrants continued evaluation.

Meanwhile, in 2014, in a study conducted by the University Of Pittsburgh School Of Medicine, a quadriplegic woman made medical history when she used a robot arm with just her thoughts to pick up a ball and other objects. For this research, small electrode grids with 96 tiny contact points were surgically implanted in the woman's brain early in 2012.

Non-invasive devices have also been used in clinical trials for a long time, though they have yet to receive approval from the FDA for commercial development.

For instance, Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos-backed Synchron implanted its device in a US patient in July 2022 without requiring cutting into the skull for installation. Its BCI is placed in a brain blood vessel and records the average firing of neuronal populations, besides enabling cursor control.

Early last year, Synchron reported findings of its human study of paralysis patients who got its Stentrode neuroprosthesis implant. The results showed that the device allowed participants to create digital switches to control a personal computing device “for routine digital activities” such as texting, emailing, and online shopping.

Then there's Precision Neuroscience, which less than a year ago announced the completion of the first-in-human procedures for a clinical study of its BCI, the Layer 7 Cortical Interface, which has 1,024 tiny electrodes embedded in a flexible film that conforms to the brain surface. With this study, which was conducted in partnership with West Virginia University's Rockefeller Neuroscience Institute, the idea was to record and map brain activity in great detail. 

While Neuralink is clearly not the first company to implant brain chips and operate a mouse just by using thoughts, given that there are about 40 BCI trials currently going on, it's good progress. Not to mention, the more companies get involved, the better it is for the BCI field, its advancement, and for humans.

Obstacles in Fully Realizing BCI Goals

As Neuralink continues to make progress, its next goal is to get as many mouse button clicks as possible from the patient. However, much like its journey so far, this road forward won't be smooth either.

It was only last year that the startup received approval for human trial recruitment. However, it wasn't until early 2022 that Neuralink sought permission from the FDA, even though Musk has predicted since 2019 that his company would start human trials of the brain implant soon.

This delay has been due to the regulatory agency FDA being concerned about the device's lithium battery and how the company can remove the device without damaging brain tissue. According to the employees of Musk's medical device company, the FDA's major safety concerns also involve the potential for the implant's tiny wires, which carry electrodes, to migrate to other areas of the brain, which can induce inflammation and impair function in the brain's critical areas.

Earlier this year, the US Department of Transportation also fined the company for failing to register itself as a transporter of hazardous material. 

Before that, in 2022, the US Department of Agriculture investigated animal cruelty at Neuralink after employees accused the company of rushing tests and botching procedures on test animals in a race for results, but the agency's inspection found no such breaches. The company faced scrutiny when a monkey died during an attempt to get the animal to play Ping Pong. 

Before the human trials, Neuralink tested its chip on monkeys and pigs, showcasing videos of monkeys “playing” basic video games via their Neuralink implants. In 2020, the startup demonstrated a preliminary coin-sized device on a pig named Gertrude, and in 2021, the chip was implanted in a macaque monkey. However, there have been reports of issues with the implants in monkeys, including brain swelling, bleeding, chronic infections, seizures, paralysis, declining psychological health, and death.

The company has since moved to human trials. In fact, after Neuralink received FDA clearance for human clinical trials, the company began recruiting patients with quadriplegia caused by cervical spinal cord injury or ALS.

Now, Musk has been sharing that the person who received the chip had fully recovered, and the first human trial produced encouraging findings. Musk, too, has commented on it. He said the human trial subject “seems to have made a full recovery” without any ill effects.

The Future: What's Next?

While Neuralink is making gradual progress. However, not everyone is feeling good about the progress. Some researchers have even shared concerns about a lack of transparency surrounding the implant, potential risks associated with brain surgery, and the ethics of animal experimentation of the brain chip. Moreover, details about the trial volunteer, too, have been scant.

According to the journal Nature, Sameer Sheth, Professor and Vice-Chair of Research at the Department of Neurosurgery at Baylor College of Medicine in Texas, Neuralink is “only sharing the bits that they want us to know about,” highlighting widespread worry within the scientific community.

Then, there are surveillance, cybersecurity, and privacy concerns, with little detail available about how the data will be used and if users will even be able to retain control of their personal data and neural activity. Scientists are further concerned about identity theft and password hacking.

Consumers, however, won't have access to the technology anytime soon as the human trials have just started, and for Neuralink's brain implants to be available widely, they first need regulatory approval. 

As for the widespread acceptance of Neuralink's technology, it will depend on the medical efficacy of the device and, of course, safety.

This is only the beginning, as BCI technology itself is still in its initial stage of development. The present technology is rather crude, and BCI research is yet to mature. At the same time, ethical issues challenge this development, calling for a need for a thoughtful approach where BCI is concerned in regards to elevating human potential.

Moreover, Musk's goal with BCI is beyond aiding patients with paralysis. He aims to help people at large “keep pace” with artificial intelligence (AI) and foster a “symbiosis” between humans and AI. In short, Neuralink's goal with its BCI technology is to eventually “unlock human potential tomorrow.”

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