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The use of non-invasive brain stimulation for mental health and more: ethics and EU regulation

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As part of an international research consortium (the EU-funded STIMCODE project), senior researcher Dr Moritz Julian Maier and his team have just developed recommendations on EU regulation and a code of conduct regarding non-invasive brain stimulation techniques: electrically or electromagnetically stimulating parts of the brain.

Much needed, because such techniques are being used more and more to treat mental disorders but they raise many ethical questions. What about treating vulnerable groups, privacy, or non-medical applications such as neuroenhancement: improving your memory or your learning abilities?

What is non-invasive brain stimulation and how does it differ from invasive methods? Why has the field gained significant attention recently?

Moritz Maier: Non-invasive brain stimulation (NIBS) allows the brain to be stimulated from the outside, on the surface of the skull. This non-surgical approach uses electromagnetic or electrical currents to target specific regions of the brain in an indirect way, known as transcranial stimulation.

Recent developments show that NIBS is becoming an increasingly promising and innovative therapy for mental disorders. It has shown potential in improving symptoms of several conditions, including depression, anxiety and schizophrenia. By modulating brain activity, these techniques offer new avenues for symptom relief and improved wellbeing.

In addition, I expect it to become even more important in the future, as increasing levels of digitalisation and artificial intelligence will make it possible to personalise treatment options and offer more and more patients the right treatment options.

How can NIBS potentially benefit patients with mental diseases?

Moritz Maier: The technology offers treatment options without many adverse side effects because it actually targets specific areas in the brain rather than the whole organism. I also see great potential in the increasing use of outpatient treatment with non-invasive brain stimulation. This would make the treatment available to people with reduced mobility or to those living in rural areas.

That is why in our recently published recommendations we call for more research into home use of non-invasive brain stimulation. In addition to technical issues, there are also questions to be answered about the privacy of medical monitoring using digital devices. It is also important that the technology is comparatively inexpensive, thereby reducing the burden on healthcare systems.

There is talk of using NIBS, next to clinical treatment, for enhancing our brain performance. This way people would get better memory and learning abilities. What ethical concerns do scientists have regarding this?

Moritz Maier: This is a very important question. Some people who participated in our research project raised some critical ethical points. For example, students were concerned that, if more and more people were to use non-invasive brain stimulation for cognitive enhancement (e.g. to improve concentration or learning), this would tremendously raise the bar for performance at university or at work. This would put pressure on everyone to use enhancement technologies.

Home users, whom we also included in our research project, were concerned that if we were to use non-invasive brain stimulation for cognitive enhancement, it could lead to a vicious circle where wealthy people could afford to buy enhancements and become wealthier. But there was also potential seen by some stakeholders we involved in our research. For people in critical positions for example, where concentration is highly relevant.

However, as a result of our latest research, we have formulated a strong recommendation that non-invasive brain stimulation should only be used for the treatment of diseases (in addition to research and diagnostics).

Are you worried about the use of NIBS in countries that bend the rules related to human rights? Are you aware of the state of NIBS research done in these countries and of any plans for future use of these technologies?

Moritz Maier: I think Europe should be aware of the fact that there are a lot of countries in the world that are using these technologies. As these regions may have different ethical frameworks, it is very important that the European Union comes up with a clear plan on how to approach NIBS. The EU institutions should really think about how they are going to position themselves on this burning issue.

As this is a very complex issue, both technologically and socially, I would like to emphasise the need for a participatory approach in the development of such a plan, taking into account different perspectives and requirements.

During Soviet times, a lot of children doing sports were administered substances that would enhance their abilities. Even now, there is news regarding Russian child athletes doping at their schools. In this new context, we will also have neuro-enhancement technologies. How should vulnerable groups, such as the elderly and children, be approached when considering NIBS as a treatment option?

Moritz Maier: This is a very important issue as it covers two critical points: vulnerable groups and misuse of neuroenhancement technologies. In our recently developed recommendations, we ask for specific treatment guidelines that we need for this set of technologies, which should definitely include answers to the questions of how to treat vulnerable groups such as children and the elderly.

In addition, as mentioned above, we have recommended that the use of non-invasive brain stimulation for enhancement purposes be strictly regulated.

Is it ethically appropriate to administer brain stimulation to individuals who are unable to provide consent due to impairment?

Moritz Maier: In my opinion, there is no such thing as a one-size-fits-all answer to this difficult question. In general, only people who have given their informed consent should receive treatment. If this is not possible, I would stress the importance of involving all relevant people, such as partners, relatives, etc. in the decision-making process related to the treatment.

Taking into account the upcoming technological findings, do you consider the development of neurorights a legislative priority?

Moritz Maier: I think I am not the right person to judge whether we need neurorights. But I am pretty sure that the impressive developments in artificial intelligence and neurotechnology will continue in the years and decades to come and that there will be many ethical and legal questions that we will have to answer. This makes it even more important for policymakers to be prepared and to have a holistic overview of technological developments and their societal implications.

The recent advancements present significant regulatory challenges for relevant authorities. With your project, you aim to develop recommendations for NIBS in collaboration with stakeholders from academia, society, industry and governmental agencies. Can you explain what STIMCODE and NIBS 2030+ are and outline the structure and goals of the NIBS recommendations?

Moritz Maier: That is absolutely right, the rapid developments in the field of neurotechnologies and thus also non-invasive brain stimulation pose many regulatory challenges. Many of the regulatory and ethical questions are so complex that a group of experts from one discipline alone can no longer answer them. Therefore, we have chosen a participatory approach involving very different groups of people with the aim of developing recommendations for non-invasive brain stimulation in the European Union in a participatory process in line with the concept of responsible research and innovation.

In the STIMCODE project we therefore invited patients, students, home users, practitioners, industry representatives, neurophilosophers and policy experts to express their wishes, concerns, ideas and comments on the topic of non-invasive brain stimulation. For this purpose, we used special design-based workshop methods that also enabled laypersons to deal with the topic comprehensively.

“NIBS 2030+” is a vision of a desirable future that summarises the results of the stakeholder workshops. Important aspects of this vision are, for example, medically supervised home treatment, personalised treatment or financing through health insurance.

This vision was presented to 15 experts from the fields of medicine, patient advocacy, neuroscience, law, ethics, innovation management, neurophilosophy and psychology, who then developed recommendations for non-invasive brain stimulation. This means that all recommendations are based on input from the participatory stakeholder workshops.

As a result, recommendations were made to the six target groups: policymakers, health authorities, healthcare providers of NIBS, Industry, researchers in industry and academia and research funding agencies. If these target groups were to follow our recommendations, this would significantly increase the likelihood of the NIBS 2030+ vision being realised.

All recommendations in detail can be found in this document.

One of your goals is to establish a governing EU-level body focused on neuroscience and neurotechnology. Why are you reaching out to EU institutions and seeking support from policymakers and what expectations do you have from public health authorities, as the interpretation of regulations can potentially vary from country to country?

Moritz Maier: Many issues that arise regarding non-invasive brain stimulation cannot be adequately addressed at a country-specific level. For example, if some countries banned non-invasive brain stimulation for performance enhancement and others did not, it would be difficult to avoid “NIBS tourism” within the EU. It is also important for the industry to avoid small-scale country-specific regulations, as these are very burdensome and can therefore inhibit innovation.

For the health authorities in the individual countries, it is then essential to cooperate with the EU-level body and to share data as far as possible, e.g. on anomalies in NIBS use.

Useful link:
STIMCODE: Participative developed recommendations for non-invasive brain stimulation in the European Union

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