No longer a fiction

Neuroimplants: Researchers call for stricter rules

What happens if neuroimplants no longer receive updates?

(Bild: stock.adobe.com)

Initial clinical tests have shown that neuroimplants that alter the physical or mental performance of fictitious people no longer belong in the realm of fiction. However, according to scientists, this raises a whole host of new questions.

For example, the scientists, including Stanisa Raspopovic from the Center for Medical Physics and Biomedical Engineering at the Medical University of Vienna, state in the journal "The Lancet Digital Health" that it is not always clearly regulated what happens to systems that have been transplanted into the body of an affected person as part of clinical tests, but whose development is then not continued. Clearly, such devices would also have to be maintained or, if necessary, removed again after the end of a study. The question of ownership must also be clearly regulated.

Systems on the move into the human body
All of these questions are now arising as the first systems are preparing to make the leap from the animal testing or prototype stage towards application in human patients, write Raspopovic, Marcello Ienca from the Technical University of Munich and Giacomo Valle from ETH Zurich in their Perspectives article.

Raspopovic has already caused a stir with a new type of prosthesis with connections to nerves in the arm, which allows patients to feel and touch again, so to speak. He also worked at ETH Zurich on a leg prosthesis that is connected to the brain via a new type of interface. He is now continuing this research in Vienna and, together with colleagues, is testing a type of electric sock to treat the loss of sensation in diabetes.

Experts argue that simply adopting the regulations for clinical trials from other areas, such as vaccine or drug development and approval, is not enough when rolling out such innovations. One example of special circumstances is the case of a paraplegic US patient who, thanks to a brain chip implant, was able to control his wheelchair as well as a computer keyboard, which enabled him to play chess, for example.

However, after the spectacular learning curve, the opposite effect set in after around a month and the controls became less precise again. Although the problem has since been partially resolved, the example illustrates the challenges, according to a press release from the Medical University.

Great opportunities and many question marks
Such implants, which can be used to establish more or less direct contact between technical devices and the nervous system, are seen by many experts as having great potential. In addition to restoring control over areas of the body where this has been lost due to strokes, for example, or the intuitive control of prostheses to replace them, chronic pain or epilepsy could also be prevented or diseases associated with a decline in mental abilities, such as Parkinson's or Alzheimer's, could perhaps be treated.

Numerous relevant studies are already underway, particularly in the USA, Canada, China, Switzerland and Germany. In Austria, however, "very few or no similar studies are being carried out", explained Raspopovic. This is primarily due to strict and lengthy approval procedures for new technologies: "On the one hand, this is good for safety, but on the other, it denies the most severely disabled patients access to the most modern treatments and devices," said the researcher.

New human-machine interfaces bring new challenges
In future, the pros and cons should be weighed up carefully: After all, due to the direct connection to the nervous system, such devices could perhaps also one day "influence consciousness, cognition and affective states and even free will", Raspopovic is quoted as saying in the press release. New approaches are therefore needed to thoroughly evaluate the direct experience of patients in studies and also to protect their privacy.

So-called human-machine interfaces offer new targets for hackers, among other things.

(Bild: Marcello Ienca,Giacomo Valle,Stanisa Raspopovic/The Lancet Digital Health)

This is because the systems must not only send out neuronal information, but also be able to record it in order to interpret it using artificial intelligence, for example. This would automatically generate and store sensitive data. What's more, every new data interface creates opportunities to tap into information or hack devices.