Neuralink Gets the Go-ahead for Human Clinical Trials

Seven years after its establishment, Neuralink has received approval from the US Food and Drug Administration (FDA) for human clinical trials of its advanced Brain Computer Interface (BCI) technology. Neuralink believes its devices can be used to overcome various illnesses and even redress disabilities. Its first aim is to enable a paralysed individual to control a computer with their mind, as already achieved in relation to monkeys. However, Neuralink continues to face various concerns associated with the invasiveness of its implants.

 

What is BCI Technology?

BCI technology transmits electrical impulses created by the brain to a computer, allowing users to control the device with their thoughts. BCI is also capable of establishing new neural pathways to mend broken ties between the brain and the rest of the body arising from physical injuries or various diseases. It achieves this by transmitting the brain signal to a computer, which then connects to another implant in the affected body part.

 

What makes Neuralink different?

BCI has been used in neuroscience since the 90s. However, Neuralink distinguishes itself from its predecessors through its innovative, streamlined design. In contrast to large computers with wires attached to individuals’ heads, Neuralink has designed a smaller implant which is inserted into the cerebral cortex. Musk has described the technology as a ‘FitBit’ for the brain.

 

The company also wants to extend the BCI concept beyond basic motor functions, such as walking. It aims to restore more complex activities such as finger movement.

 

Additionally, Neuralink’s model replaces traditional metal spikes used in BCI implants, including industry standards such as the Utah Array, with thin, malleable wires while allowing more information to be transmitted. This development is essential for Neuralink to achieve its aims of curing brain diseases and amending physical injuries.

 

ChallengeS

Until now, Neuralink has only conducted trials on animals, in particular monkeys. Recordings demonstrating tests on a monkey named Pager from the last two years have been released online. They showcase how the implants have enabled Pager to play a video game and manoeuvre a cursor with its thoughts.

 

These achievements must be considered alongside ethical concerns. Neuralink has been accused of killing over 1,000 animals. Although precise numbers remain unknown, one reported trial revealed that after 25 pigs received implants of the wrong size, 2 of them died.

 

This has led to apprehensions regarding human trials. Further concerns have been raised about the storage and protection of brain data. For now, the precise impact of leaking patients’ cognitive activities remains unknown.

 

Conclusion

Overall, despite the FDA’s green light for human clinical trials, Neuralink’s potential to improve human health will have to be balanced alongside a range of ethical and practical concerns.

 

By Alexander McLean