Neuralink Receives Approval for Human Trials of Brain Implant to Treat Paralysis
Elon Musk’s neurotechnology company, Neuralink, has received the green light to begin recruiting patients for groundbreaking human trials of its brain implant designed to help those with paralysis. The company has gained approval from an independent review board and a hospital to move forward with the clinical trial.
The trial, known as the PRIME study, will involve the use of a robot to surgically implant a wireless brain-computer interface (BCI) in the region of the brain responsible for controlling movement intention. This implant, which is “cosmetically invisible,” will wirelessly record and transmit brain signals to an app that decodes movement intention.
Neuralink, founded by Elon Musk in 2016, aims to develop the first neural implant that allows individuals to control computers or mobile devices with their minds. The upcoming trial, expected to span six years, will assess the safety and initial effectiveness of the implant, enabling participants to control a computer cursor or keyboard using their thoughts alone.
The human trial conducted by Neuralink has been granted approval by the Food and Drug Administration under the investigational device exemption (IDE). The company previously conducted successful brain implant tests on animals, including the implantation of artificial intelligence microchips in a pig named Gertie.
X (formerly Twitter) CEO Elon Musk leaves a US Senate bipartisan Artificial Intelligence (AI) Insight Forum at the U.S. Capitol in Washington, on Sept. 13, 2023. (Mandel Ngan/AFP via Getty Images)
Concerns Over Animal Research
In April 2021, Neuralink faced criticism for its animal research practices after a video showed a macaque named Pager playing computer games through a neural implant. The company has been under investigation by the U.S. Department of Transportation for potential violations related to the transportation of hazardous pathogens.
Separately, Reuters reported that Neuralink is also being investigated by the U.S. Department of Agriculture’s Office of Inspector General for potential violations of the Animal Welfare Act. Elon Musk has defended the company’s animal research, stating that the monkeys used in trials are happy and well-cared for.
According to a Neuralink brochure, the human trial will consist of a primary study, BCI research sessions, and long-term follow-ups. Participants will undergo nine at-home and in-person clinic visits in the first 18 months, along with twice-weekly research sessions lasting one hour throughout the study. Additionally, they will complete 20 long-term follow-ups over five years.
Gert-Jan Oskam, 40, victim of a spinal cord injury that left him paralyzed, poses with his implants that allows him to walk naturally during a press conference in Lausanne, Switzerland, on May 23, 2023. (Fabrice Coffrini/AFP via Getty Images)
Trial Eligibility
To be eligible for the study, participants must be at least 22 years old, have quadriplegia due to spinal cord injury or ALS, and have shown no improvement for at least one year. They must also have a consistent and reliable caregiver. Neuralink stated that this study is a crucial step towards their mission of creating a generalized brain interface to restore autonomy for those with unmet medical needs.
Neuralink is one of several organizations exploring the use of implants to assist individuals with paralysis. Recent breakthroughs include a brain-computer interface that enabled a severely paralyzed stroke survivor to communicate again, and an implant that allowed a paralyzed man to walk by simply thinking about it.
As of June, Neuralink has been valued at $5 billion.
Mimi Nguyen Ly and Reuters contributed to this report.
How can collaboration with healthcare providers and insurance companies ensure that Neuralink’s brain implant is accessible and affordable to individuals who need it most
Euralink is being investigated by the U.S. Department of Agriculture due to concerns regarding its treatment of animals used in experiments. Animal rights activists have raised concerns about the welfare of the animals involved and have called for greater transparency and ethical practices in the field of neurotechnology research.
Despite these concerns, the approval of Neuralink’s human trials represents an important step forward in the development of brain-computer interfaces and the treatment of paralysis. Paralysis is a devastating condition that affects millions of people worldwide, limiting their ability to move and communicate. The potential of Neuralink’s technology to restore mobility and improve the quality of life for paralyzed individuals is truly groundbreaking.
The outcome of the PRIME study will not only provide valuable insights into the safety and effectiveness of Neuralink’s brain implant but also pave the way for future advancements in the field. If successful, this technology could revolutionize the way we interact with computers and facilitate a direct connection between the human brain and digital devices.
However, it is crucial to approach this technology with caution and address the ethical implications it raises. The ability to read and manipulate brain signals raises ethical concerns regarding privacy, consent, and potential misuse. Comprehensive regulations and guidelines must be established to ensure the responsible and ethical use of brain-computer interfaces.
Furthermore, the cost and accessibility of this technology will be a key factor in determining its impact. It is essential to ensure that Neuralink’s brain implant is accessible to those who need it most, regardless of their socioeconomic status. Collaboration with healthcare providers and insurance companies will be crucial in making this technology widely available and affordable.
The potential benefits of Neuralink’s brain implant are immense, offering hope to individuals with paralysis and potentially revolutionizing the field of neurotechnology. The approval of human trials is a significant milestone, but it is just the beginning. Continued research, collaboration, and ethical considerations will be essential in harnessing the full potential of brain-computer interfaces to improve the lives of those with paralysis and other neurological conditions.
As we embark on this exciting journey, it is important to remember the importance of responsible innovation and to prioritize the well-being and autonomy of the individuals who will benefit from this technology. Neuralink’s human trials mark a significant step forward, but the true impact of this technology will depend on how we navigate the ethical challenges and ensure equitable access for all.
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