Elon Musk’s brain-computer interface company, Neuralink, recently made headlines by announcing the successful implantation of a device in a human for the first time. The company’s PRIME study, which aims to develop a brain implant that allows people with paralysis to control external devices using their thoughts, has received approval from the US Food and Drug Administration.
While this achievement is significant for a company that is less than ten years old, Neuralink still faces numerous challenges. The company has previously faced scrutiny for its treatment of lab animals and has seen the departure of several executives. Additionally, the process of implanting a device is just the beginning of a long-term clinical project that will involve competition from other companies, financial obstacles, and ethical dilemmas.
The development of brain-computer interfaces has been ongoing for decades. The first demonstration of such technology took place in 1963 when neuroscientist William Grey Walter connected a patient’s brain to a projector, allowing them to advance slides using their thoughts. The current wave of research in this field began in the early 2000s and builds upon studies from the 1940s and 1990s that explored brain activity and conducted experiments on animals.
Neuralink’s technology represents the next generation of recording devices. These devices have multiple electrodes, offer greater precision, are safer and longer-lasting, and are more compatible with the human body. Compared to existing brain-computer interfaces like the “Utah array,” Neuralink’s implant is thinner, smaller, and less obtrusive. It contains 3,072 electrodes, far surpassing the 100 electrodes found in the Utah array.
Neuralink faces tough competition in the race to commercialize next-generation brain-computer interfaces. One of its main rivals is an Australian company called Synchron, which has developed a minimally invasive brain-computer interface using a microelectrode mesh threaded through the blood vessels of the brain. Synchron has already received a “Breakthrough Device Designation” in the US and is currently conducting its third clinical trial.
The competitive landscape raises ethical concerns regarding the welfare of patients participating in the PRIME study. Recruiting participants for neural implant studies is notoriously challenging, as strict eligibility criteria and inherent risks make it difficult to find suitable candidates. While Elon Musk’s public profile may help Neuralink attract participants, the company must be prepared to provide long-term support to patients, potentially spanning decades. Additionally, there is a need for a plan to address potential issues if the company ceases operations or if the devices stop working.
The hype surrounding Neuralink may also impact the process of obtaining informed consent from potential participants. Musk’s comparison of the implant to a “Fitbit in your skull” and the device’s misleading name, “Telepathy,” could create unrealistic expectations and downplay the risks involved, including the possibility of severe brain damage.
Moving forward, Neuralink must prioritize research integrity and patient care. The company’s establishment of a patient registry to connect with patient communities is a positive step. Long-term planning and careful use of language are crucial to prevent harm to patients and their families. It is essential to avoid repeating past mistakes, such as the disastrous pre-frontal lobotomy experiments of the 1940s and 1950s, which had severe consequences for patients and set back research in the field for generations.
