Neuro-implants: Researchers call for stricter rules

For example, it is not always clearly regulated what happens to systems that have been transplanted into the body of an affected person in the context of clinical tests, but whose development is subsequently not continued, said the scientists, including Stanisa Raspopovic from the Center for Medical Physics and Biomedical Technology from the Medical University of Vienna count in the journal “The Lancet Digital Health”. Naturally, such devices must be maintained or, if necessary, removed again after an examination. The issue of ownership must also be clearly settled.

Systems en route to the human body
All these questions are now coming to the fore as the first systems prepare to make the leap from animal testing or prototype phase to use in human patients, write Raspopovic, Marcello Ienca of the Technical University of Munich and Giacomo Valle of ETH Zurich in their perspective. article.

Raspopovic has already caused a stir with a new type of prosthesis with connections to nerves in the arm, allowing patients to feel and touch something again, as it were. He also worked at ETH Zurich on, among other things, a prosthetic leg that is connected to the brain via a new interface. He is now continuing this research in Vienna and, together with colleagues, is testing a type of electric socks to treat loss of sensation in diabetes.

When rolling out such innovations, simply copying clinical trial regulations from other areas, such as vaccine or drug development and approval, is not enough, the experts argue. An example of special circumstances is the case of an American patient with a spinal cord injury who, thanks to a brain chip implant, was able to control both his wheelchair and a computer keyboard, allowing him to play chess, for example.

After the spectacular learning curve, however, the opposite effect occurred after about a month and the steering became less accurate again. The problem has now been partially solved, but the example shows the challenges, according to a press release from Meduni.

Great opportunities and many question marks
Many experts believe that such implants, which can be used to establish more or less direct contact between technical devices and the nervous system, have great potential. In addition to restoring control over parts of the body where it has been lost due to, for example, a stroke, or intuitively controlling prostheses that replace them, chronic pain or epilepsy can also be prevented, or diseases that are related to a deterioration of mental health. have disabilities, such as Parkinson’s or Alzheimer’s, may need treatment.

Numerous relevant studies are already underway, especially in the US, Canada, China, Switzerland and Germany. In Austria, however, “very few, if any, similar studies are conducted,” Raspopovic explains. This is mainly due to strict and lengthy approval procedures for new technologies: “On the one hand this is good for safety, but on the other hand it denies the most severely disabled patients access to the most modern treatments and devices,” says the researcher.

New human-machine interfaces bring new challenges
In the future, the pros and cons must be carefully weighed: due to the direct connection to the nervous system, such devices might one day “influence consciousness, cognition, affective states and even free will,” Raspopovic is quoted as saying . say on the air. Therefore, new approaches are needed to thoroughly assess patients’ direct experiences with research studies and also to protect their privacy.

The systems must not only transmit neural information, but also be able to record it so that it can be interpreted, for example, with the help of artificial intelligence. This would automatically generate and store sensitive data. And: every new data interface creates opportunities to access information or hack into devices.