Potential risks arise as Neuralink implants its first chip into a human brain. What are the potential consequences?

Elon Musk made an announcement last week regarding his company Neuralink, stating that they have successfully implanted a device in a human for the first time. The company’s PRIME study, which received approval from the US Food and Drug Administration in the previous year, aims to test a brain implant that enables individuals with paralysis to control external devices using their thoughts.

Over the past few years, Neuralink has been under investigation for the mistreatment of laboratory animals and the resignation of several company executives. Nevertheless, the PRIME experiment is a significant milestone for a company less than ten years old.

However, Neuralink’s challenges are far from over. Implanting the device is just the beginning of a decades-long clinical project fraught with competitors, financial hurdles and ethical dilemmas.

Decades of development

The first reported demonstration of a brain-computer interface was in 1963. In a lecture at Oxford University, neuroscientist William Gray Walter amazed his audience by connecting one of his patients’ brains to a projector, where they advanced the slides of their presentation using only their thoughts.

We are on WhatsApp channels. Click to join.

However, the current wave of research into the use of brain recording techniques to restore movement and communication to patients with severe paralysis began in the early 2000s. It is based on studies in the 1940s that measured the activity of individual neurons, and more complex experiments on rats and monkeys in the 1990s.

Neuralink’s technology belongs to the next generation of storage devices. They have multiple electrodes, greater accuracy, and are safer, more durable, and more compatible with the body. The Neuralink implant is thinner, smaller and less intrusive than the “Utah array” device widely used in existing brain-computer interfaces, which has been available since 2005.

Neuralink’s device is implanted by a special robot that rapidly feeds polymer wires, each of which contains dozens of electrodes. The device has a total of 3,072 electrodes, which dwarfs the 100 electrodes of the Utah group.

Competitors

Neuralink faces stiff competition in the race to commercialize the first next-generation brain-computer interface.

Without a doubt, its fiercest competitor is an Australian company called Synchron. This Melbourne-based start-up recently used a network of microelectrodes threaded through the blood vessels of the brain. This allowed paralyzed patients to use tablets and smartphones, surf the Internet, send emails, manage their finances (and post on X, formerly Twitter).

The Synchron implant is described as a “minimally invasive” brain-computer interface. It only requires a small incision in the neck, rather than the complex neurosurgery required by Neuralink and most other brain-computer interfaces.

In 2021, Synchron received a “Breakthrough Device Designation” in the US and is now in its third clinical trial.

Patient well-being

This competitive environment raises possible ethical questions about the patients’ well-being in the PRIME study. First, it is notoriously difficult to recruit participants for neural implant studies. Patients must meet strict criteria to be eligible, and studies are inherently risky and require large numbers of participants.

Musk’s public profile can help Neuralink find and enroll suitable patients. However, the company must be prepared to provide long-term support to patients (possibly decades). If things go wrong, patients may need support to live with the consequences. If things go right, Neuralink might have to make sure the devices don’t stop working.

In 2022, a company called Second Sight Medical Product demonstrated the risks. Second Sight made retinal implants to treat blindness. When the company went bankrupt, more than 350 patients around the world had outdated implants that could not be removed.

If Neuralink’s devices are successful, they will likely change the lives of patients. What happens if the company goes out of business because it can’t make a profit? A long-term care plan is essential.

In addition, the high hype surrounding Neuralink may have implications for obtaining informed consent from potential participants.

Musk famously likened the implant to a “Fitbit in your skull.” The device itself, Musk recently revealed, is misleadingly called “Telepathy.”

This technofuturistic language may give participants unrealistic expectations about the likelihood and type of individual benefit. They may also underestimate the risks, which can include serious brain damage.

The way forward

In this next chapter of the Neuralink odyssey, Musk and his team must maintain a strong commitment to research integrity and patient care. The establishment of Neuralink’s patient registry to connect with patient communities is a step in the right direction.

Long-term planning and careful language are essential to prevent harm to patients and families.

The nightmare scenario for all neuroengineering research would be a repeat of Walter Freeman’s disastrous prefrontal lobotomy experiments in the 1940s and 1950s. These had catastrophic consequences for patients and set research back generations.