Neuralink, the company led by entrepreneur Elon Musk, has successfully implanted a device that can read brain activity into a person for the first time. Musk shared this exciting news in a tweet on 29 January.
BCIs are designed to capture and interpret brain activity, enabling individuals with severe paralysis to operate a computer, robotic arm, wheelchair, or other devices using only their thoughts. In addition to Neuralink’s device, there are other devices currently being developed and some have already undergone testing in individuals.
Neurotechnology researchers are filled with a sense of cautious excitement regarding Neuralink’s upcoming human trial. I would like to see them provide evidence of its safety. “It has been found to be effective in measuring brain signals, both in the short term and, more importantly, in the long term,” states Mariska Vansteensel, a neuroscientist at University Medical Centre Utrecht in the Netherlands and president of the international BCI Society.
However, many people are feeling frustrated due to the limited amount of specific information available. It remains uncertain whether the trial has commenced, as there has been no official confirmation apart from Musk’s tweet. A study brochure inviting people to participate in the trial serves as the primary source of public information. However, Tim Denison, a neuroengineer at the University of Oxford, UK, points out that more specific information is needed regarding the locations of the implantations and the specific outcomes that will be assessed in the trial.
The trial is not listed on ClinicalTrials.gov, an online repository maintained by the US National Institutes of Health. It is common for universities to request that researchers register a trial and its protocol in a public repository before enrolling study participants. In addition, numerous medical journals require registration as a prerequisite for publishing results, aligning with ethical principles that safeguard individuals who participate in clinical trials.
Scientists explores the comparison between Neuralink’s implants and other BCI technologies, the potential advancements in BCIs through the trial, and the concerns raised by researchers.
What sets the chip apart from other BCIs?
Similar to Blackrock Neurotech in Salt Lake City, Utah, Neuralink also focuses on the activity of individual neurons. This particular approach necessitates the use of electrodes that are capable of penetrating the brain. Several companies are working on the development of electrodes that can be placed on the surface of the brain. These electrodes are designed to record signals generated by groups of neurons and can be easily removed if needed. Neuroscientists have extensively discussed the necessity of data from individual neurons for advanced thought-decoding. However, recent research suggests that by analyzing averaged signals, scientists can gain insights into intricate cognitive processes, such as inner speech1. Synchron, a company based in New York City, has demonstrated the effectiveness of a low-bandwidth surface BCI in providing reliable smartphone control.
Similar to the Synchron system, Neuralink’s technology is completely implanted and wireless. It is quite remarkable that BCIs are now able to record from individual neurons. In the past, these systems required a direct physical connection to a computer via a port in the skull. This presents a potential risk of infection and restricts its practical application in real-life scenarios.
According to the company’s study brochure, the Neuralink chip is equipped with 64 flexible polymer threads, which offer a total of 1,024 sites for recording brain activity. That is significantly higher than the number of Blackrock Neurotech’s BCIs, which is the only other single-neuron recording system that has been implanted in humans for a long period of time. The Neuralink device has the potential to significantly enhance brain-machine communication, as observed in users who have multiple Blackrock devices implanted. Neuralink highlights the remarkable flexibility of its threads and shares its ongoing efforts to create a specialized robot for their precise insertion into the brain.
Denison expresses enthusiasm for the wide range of approaches. Now it’s a matter of determining which options excel in terms of safety, signal quality, durability, and user experience. “It is important for all of us to think long-term and prioritize the well-being of patients,” he states.
What will scientists learn from the Neuralink human trial?
Neuralink has been quite secretive about the goals of its trial and has not provided any information in response to the reporter’s interview request. However, safety is expected to be of utmost importance at this stage, according to experts. According to Denison, it is important to carefully observe the immediate effects of the device, such as the absence of strokes, bleeds, or damage to blood vessels. Additionally, it is crucial to monitor for any infections and conduct long-term follow-up to ensure the continued safety of the implanted device.
According to Neuralink’s study brochure, volunteers will be closely monitored for a period of five years. Additionally, the trial will evaluate the device’s functionality by having volunteers use it at least twice a week to control a computer and provide feedback on their experience.
Vansteensel is interested in understanding if the detected neuronal signals deteriorate over time, as is often observed in current devices. “Replacing electrodes after implantation is not an easy task,” she mentions. If, in a month from now, they show remarkable decoding results—quite impressive. However, I am interested in observing the outcomes over an extended period of time.
Denison is also interested in understanding the performance of a wireless system in real-world environments, outside of laboratory settings.
Scientists have expressed concerns regarding the Neuralink BCI
Now that trials involving humans have commenced, ensuring the safety and well-being of the volunteers is a matter of utmost importance. The trial received approval from the US Food and Drug Administration (FDA) after an earlier application from Neuralink was rejected. However, certain researchers express concern about the trial not being listed on ClinicalTrials.gov. Denison suggests that the FDA and Neuralink are likely following a similar approach. “However, we currently do not possess the necessary protocol.” So we don’t have that information.
Transparency is a crucial aspect for the individuals who benefit from BCIs. Ian Burkhart, a co-founder of the BCI Pioneers Coalition located in Columbus, Ohio, experienced paralysis due to a diving accident that resulted in a broken neck. For a duration of 7.5 years, he had a Blackrock array implanted in his brain. He is enthusiastic about the potential accomplishments of Neuralink. According to him, there is room for improvement in the amount of information being released, as opposed to leaving everyone to speculate. Especially for the patients who are eagerly anticipating the arrival of this technology to enhance their lives.
