Bengaluru: The US Food and Drug Administration (FDA) has given the green light to Neuralink, a company founded by Elon Musk, to conduct human trials in brain-computer interface (BCI) technology. This technology involves implanting a tiny chip in the brain that can read and interpret neural signals.
Founded in 2016, the company aims to treat brain diseases and eventually perform human enhancement and augmentation, where biological implants theoretically alter the body to improve physical and mental capabilities. It has been conducting trials in animals like monkeys and pigs since 2018.
However, the company has also faced criticism and scrutiny for its treatment of animals and its management practices. The US Department of Agriculture (USDA) even has the company under investigation for violating animal welfare laws through careless testing without safety.
Engineers and researchers have reportedly expressed concerns and criticisms over the Neuralink BCI project, stating that Musk’s demonstrated technology has been in existence since 2002 with other BCI projects and have criticised its ability to enhance brain functions without enough scientific knowledge about it.
His ideas for human enhancement, they said, could create more division in society by increasing inequality.
Last year, the FDA rejected Neuralink’s application for human testing, citing safety concerns over the device’s design and functionality. It raised doubts about the device’s ability to move in the brain without causing damage, to be removed safely, if needed, without brain tissue damage, and to operate with a lithium battery.
This month, the FDA approved human clinical trials for Neuralink.
Neuralink has been very secretive about its work and research, revealing only a few details to the public. In 2021, the company showed a video of a monkey playing a video game called Pong by using only its brain signals to control the cursor.
Neuralink is not the only player in the field of BCI. There are many other researchers and institutions that have been developing and using BCI for various purposes, including restoring vision, movement, and speech in people who have lost these abilities due to injury or disease.
ThePrint explains what BCI is, how it works, and what Neuralink plans to do with it.
What is BCI and how does it work
BCI is a technology that connects the brain with external devices, such as computers or robots, using electrical signals. The human brain produces oscillating patterns of activity, called brainwaves, that reflect different mental states. These brainwaves can be measured by an electroencephalogram or EEG.
BCIs — the development work of which began in the 1960s and 70s — can be invasive or non-invasive, depending on the objective.
Non-invasive BCI uses external equipment that can sense brain signals through an EEG without penetrating the skull, and then use those signals to control external objects. The first non-invasive EEG control of a physical object was performed in 1988.
Two years later, bidirectional control was established, where an external source could modify the brain signal as well. Devices were able to induce a state of expectation in the brain, thus modifying brainwaves as well.
Invasive BCI, which became popular in the 2000s, involves surgically implanting a chip or a fibre into the brain that can directly read and write neural signals.
Many labs and universities have shown monkeys and rats with implants being able to perform tasks on external objects with their neural signals alone, or by just thinking about it.
These neural signals have also been captured by computers, which then decode them and transmit them to motor or movement neurons, recovering mobility in impaired animals and people.
A similar process is used to restore vision, as well as recording typed language output in people without arms and/or spinal cord injuries.
Concerns and limitations
BCI is a very expensive and complex technology and has many limitations and dangers.
For example, volunteers in experiments with BCIs have to remain very still, and there are unknown long-term effects of having a chip in the brain. There is also a high risk of misuse or abuse of the technology.
For the future, there are already many ethical and social issues related to BCI. There are concerns around mind reading and lack of privacy, as well as the ability to track an individual and use technology to gain information. It could also lead to greater discord in society through abuse or selective use of the technology.
There are also ethical concerns around informed consent from those who are impaired in communication or are in ‘vegetative states’ (brain dysfunction) or coma, and worries about equitable access.
While today the technology is limited to very basic and experimental benefits, Musk has reportedly stated that he founded Neuralink because he believes artificial intelligence to be a “threat to humanity”. For the future, he envisions the device to be similar to a video game where the brain reverts to the last saved state.
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Neuralink evolution
The company, which is headquartered in California, was founded in 2016 by a team of eight members, including Musk and seven other scientists and engineers. It conducts research in partnership with the University of California Davis.
As of 2023, only two of the original team of the eight remain with the company.
In January last year, the company was reportedly criticised for its work culture of “blame and fear” and mismanagement.
In February last year, Neuralink was hit with accusations that the company along with UC Davis had mistreated several monkeys and subjected them to physical and psychological distress as well as chronic and painful infections from surgeries, which was reported widely.
Among 23 macaque monkeys involved in research, the complaints by the Physicians Committee for Responsible Medicine, an animal-welfare-in-research advocacy group, reportedly stated that 15 died or were euthanised, and that evidence for this was withheld.
Neuralink, according to a Reuters report, stated that macaque monkeys died and were euthanised after experimentation and not during experiments. It also denied that animal abuse had occurred. However, an investigation from this week — published in WIRED — revealed “gruesome” details about the mistreatment of the monkeys.
In December 2022, Neuralink was also reported to be under federal investigation by the USDA for animal abuse, and the investigation quoted ex-employees as saying that Musk’s demand for quick results led to the suffering and deaths of the monkeys, Reuters reported. The investigation is still ongoing.
This year, approval for human testing was obtained in September, with the company to begin recruitment for the trials soon. The trials will see a surgical robot called R1 implant ultrafine BCI fibers from a chip called N1 in the areas of the brain that control movement.
The initial objective is stated as enabling people with paralysis to control a computer’s cursor with their thoughts. The decision, however, has again raised alarms and ethical concerns among scientists.
(Edited by Richa Mishra)
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