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Neuralink Approved for Human Brain-Implant Trial Recruitment

Neuralink is one of several neurotechnological companies currently developing implantable brain-computer interfaces. The company was founded by Elon Musk and a team of seven scientists and engineers in 2016, with current CEO Jaren Birchall.

This year, after having been given official FDA approval, the company hired a clinical trial director, as it moves towards testing chip implants in humans. But when, and if human testing starts, what would this major step mean for brain implant science, and what ethical questions still need answers?

After a culmination of breakthroughs by brain-machine interface (BMI) researchers, this landmark moment for the field of neurotechnology has generated widespread curiosity about the potential implications for future human-machine boundaries, medical treatments, and general understanding of the human brain.

Approval by the U.S. Food and Drug Administration is no mean feat. The FDA doesn’t typically confirm approvals for human clinical trials but offered a statement: “The FDA acknowledges and understands that Neuralink has announced that its investigational device exemption … for its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device,” an agency spokesperson said in a statement Friday.

The chip itself is groundbreaking. Dr. Paul Nuyujukian, director of the Brain Interfacing Laboratory at Stanford's Wu Tsai Neurosciences Institute, states, in a 2022 interview with WIRED, that “for about 20 years now, academic research brain implants, up until this point, have been almost exclusively with wires. The difference that the N1 has with Neuralink, is that it is fully implantable, it's battery powered and wireless. All of this is being done over Bluetooth protocol”.

This human-brain implant trial aims to address conditions such as paralysis, brain injuries and other neurological disorders (where the neural pathway from the brain to the target muscle is damaged) by developing a direct connection between the brain and external devices, using neuro-electrophysiological recordings.

In paralysis, damage in the pathway from the brain to the muscle prevents signals from the brain from reaching the muscles, preventing voluntary movements. Dr. Paul Nuyujukian explains that, in many cases, the signals are still present in the brain, but it is simply the connection to the muscle that is lost. Therefore, if one was to reach in and listen to those neurons, researchers would know how the muscle reacts in real time and gain a better understanding of how these neurons affect body movement, which is ultimately the goal of a brain implant.

The current aim of this is to allow quadriplegic individuals to control computers and mobile devices with their thoughts. Future goals include restoring speech, vision, and motor function, and eventually “expand how we see the world".

Participants in the trial will undergo a careful screening process to ensure their eligibility. Once selected, they will have Neuralink’s brain implant surgically placed in their brain. The implant will consist of tiny, flexible threads known as the BMI devices. According to the company, these threads are thinner than human hair and can be inserted into the brain with minimal disruption.

This chip, will allow direct communication between the human brain and external devices.

These BCIs typically involve the implantation of electrodes or other sensors into the brain to record neural activity. The implanted electrodes are used to record electrical signals generated by neurons in the brain and carry information about a person's intentions, thoughts, and movements. Neuralink's technology involves sophisticated algorithms and machine learning techniques to decode and interpret neural signals. This allows the system to understand the user's intentions and translate them into specific actions or commands. According to the company, once the neural signals are decoded, they can be used to control external devices, such as computers, prosthetic limbs, or even robotic exoskeletons. For individuals with paralysis, this means they could potentially regain control over their limbs or interact with their environment using their thoughts.

There are potential benefits to this new technology, such as the restoration of lost functions, which would help patients regain mobility and independence, and lead to an improved understanding of the brain, providing valuable data and insights into how the human brain functions, potentially advancing our understanding of neurological disorders.

However, similar to any clinical trial, the development and use of brain implant technology also raises some important ethical considerations. As Courtney Worrell shares in her 'Transforming the future of Clinical Trials' article, clinical trials are research studies that test a medical, surgical, or behavioural intervention in people. So, whilst many clinical trials raise similar questions and concerns, this very new technology requires extra consideration in particular.

Many of these include public concerns over data privacy, consent, and potential misuse. Even though Neuralink have expressed their commitment to address these issues and ensure the public on the responsible and ethical development of their technology, these issues remain complex and demand careful examination.

One of the foremost concerns revolves around informed consent. Participants must fully understand the risks, benefits, and potential consequences of the procedure. Given the irreversible nature of the brain implant, ensuring informed consent is critical and it is therefore essential for the participants to enter this procedure willingly and with full comprehensive understanding of the technology, forcing the company to fully disseminate its methods and techniques. However, Neuralink are yet to comment on this concern and showcase its road forward.

Another dominant concern relates to privacy and data security. Brain implants have the capability to record, transmit and store vast amounts of personal data. Therefore, ensuring the safekeeping of this sensitive information is paramount. Both researchers and companies conducting these trials will need to implement robust data protection measures and adhere to strict ethical standards regarding data access, sharing and storage, as mishandling of this data could have serious consequences for patients and their respective communities.

There is a concern that access to advanced neurotechnology might worsen existing social and economic differences. If brain implants become available primarily to those with financial means, CNBC suggests it could lead to a two-tiered society where some have access to enhanced cognitive abilities, whilst others do not. Ethical guidelines must ensure that these technologies are kept within their legal ramifications and ensure they are accessible to a broader population, including those from disadvantaged backgrounds.

Overall, Neuralink’s approval for human-brain implant trial recruitment represents a significant milestone in the field of neurotechnology. On one hand, it offers hope to individuals with neurological disorders and presents a glimpse into a future where humans and machines can interact together in unprecedented ways. However, as technology continues to develop and as we move forward, it is essential to consider the ethical implications of such developments and ensure that these technologies are developed in a responsible and transparent manner.

The journey towards unlocking the full potential of the human brain has begun, but striking a balance between innovation and ethical responsibility is essential for all.


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