Non-Invasive Brain Stimulation procedures: Increasingly Essential for Healthcare

New Fraunhofer white paper: recommended actions for development and implementation of “Non-Invasive Brain Stimulation” (NIBS) therapies elaborated

Technical therapy solutions for the health of EU citizen:s – Scientists:s call for the use of non-invasive brain stimulation methods: In a white paper, the “Center for Responsible Research and Innovation (CeRRi)” of the Fraunhofer Institute for Industrial Engineering (IAO), in collaboration with the University of Göttingen and international partners, has drawn up guidelines for the development and introduction of “Non-Invasive Brain Stimulation (NIBS)”. In their guidelines, they present “a shared vision of the use of NIBS as a desirable future in the EU” ¹.

The numbers are well known: According to forecasts, the number of patients with neurodegenerative diseases, above all Alzheimer’s and dementia, could rise to over three million in Germany by 2050. Across Europe, about 18.8 million people are then expected to be affected, and worldwide, about 153 million people will have dementia – up from 57 million in 2019, according to the widely cited study published in The Lancet Public Health ².

In addition, there is a sharp increase in mental illness. Currently, about 27.8 percent of adults in Germany, or about 17.8 million people, are affected by a mental illness (DGPPN January 2023). The Corona pandemic has again significantly exacerbated the situation: worldwide, for example, the number of depressions increased by about 25 percent in the first year of the COVID-19 pandemic, corresponding to almost 280 million people affected ³.

In light of these developments, medicine, health care systems, and policy makers face major challenges in terms of care structure and the urgent need to expand therapeutic options. Noninvasive methods of brain stimulation, abbreviated as NIBS, which modulate brain activity through electrical, magnetic, or other forms of physical energy, may play a significant role in the therapy of mental and neurological disorders in the future, according to an increasing number of scientists:ing and institutions.

“Of crucial importance” for a healthier future: Technical therapy solutions

To this end, the “Center for Responsible Research and Innovation (CeRRi)” of the Fraunhofer Institute for Industrial Engineering IAO, in collaboration with the University Hospital of Göttingen and international partners, has summarized guidelines for the development and introduction of “Non-Invasive Brain Stimulation (NIBS)” and published their “Recommendations for Non-Invasive Brain Stimulation in the European Union” in a “White Paper” ¹.

The panel, consisting of experts from the fields of neuroscience, medicine, law, ethics, innovation management, philosophy, and psychology, strongly advocates the increased use of various brain stimulation techniques that are accessible to all patients, in light of current and expected disease rates.

NIBS, the participatory-developed whitepaper states, help to produce an improvement in mental health and well-being in the general population, are capable of contributing to an improvement in personalized and outpatient treatment, and ultimately, are better able to control the exorbitantly rising healthcare costs in most EU countries.

Whitepaper: Benefits of non-invasive brain stimulation methods could “revolutionize” the treatment landscape

Recent developments, the panel said, show NIBS to be increasingly promising and innovative therapies. Here, they cite as examples transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), which have already demonstrated their potential to improve symptoms of various disorders, including depression, anxiety, and schizophrenia.

These and other NIBS methods would therefore need to be intensively researched in terms of their underlying mechanisms, potential benefits, and risks, with efficacy and safety as the first priority.

Education, accessibility to therapies, and closer collaboration between research and industry called for

In a 6-point plan, the authors summarize their recommendations, addressing policymakers, health authorities, health care providers, industry, and research alike. In doing so, they clearly show that a comprehensive reform of the healthcare system will be necessary that implements technical solutions in the field of therapy across the board.

In summary, the Fraunhofer guide for the entire European Union recommends:

1. Policy makers: Establish a governing body at EU level for neuroscience and neurotechnology, including NIBS; ensure patient:s equal access to safe and effective NIBS; engage all relevant stakeholders in public discussion on medical, ethical, social, legal, and political aspects of NIBS; ensure data protection by establishing data management and special data protection (neurorectification).
2. Health authorities: Commitment of health authorities to keep the general public fully informed about the latest developments in NIBS technologies; support the EU-level body mentioned in point 1; ensure quality standards for NIBS; support the development of new, promising NIBS.
3. Healthcare providers: Involve all relevant stakeholders and health professionals and representatives in treatment decisions and processes; improve the treatment environment and equipment; physicians working with NIBS technologies should receive additional certification.
4. Industry: Develop more NIBS for home use for medical purposes to make this new technology accessible to all; provide safe data collection in the home.
5. Research and Industry: Encourage and support research to intensively explore NIBS technologies; this should lead to individualized therapy options, biomarker determination for therapy monitoring, and more individualized, precision-guided treatments.
6. Research Funding Agencies: Increased funding for research on efficacy, biomarkers, and potential home use; increase opportunities for exchange between industry and academia; provide open access for research and academia; and provide incentives for private organizations, i.e., the media, to report on neurotechnologies.

Thus, the white paper, which was promoted and funded, among others, by the German Federal Ministry of Education and Research (BMBF), takes into account the demand of numerous associations, institutions, scientists:inside, the medical technology industry, physicians:inside and, not least, patients:inside already treated with NIBS technologies and their relatives:

The already available therapy options for non-invasive neurostimulation should and can enable the urgently needed turnaround in neurology and psychiatry. Making NIBS comprehensive and universally accessible to patient:ing alongside established pharmaceutical treatment pathways is an important and necessary step toward comprehensive health care accessible to all that can meet current and future needs.

The white paper “STIMCODE. Participative developed recommendations for non-invasive brain stimulation in the European Union” can be downloaded for free at the following link:

https://publica.fraunhofer.de/entities/publication/c305e42c-4c07-497c-8860-460ccb5e0a7c/details

Sources:

¹ Maier, M. J., Antal, A., Oliviero, A., Breuer, J., Ramasawmy, P., Baeken, C., Hölzle, K., Paulus, W., Rozynska, J., Ryan, D., Salardi, S., Tankisi, H., Vidalis, T., Zilio, F., & Northoff, G. (2023). STIMCODE Participative developed recommendations for non-invasive brain stimulation in the European Union. Fraunhofer Publica. https://dx.doi.org/10.24406/publica-1569.

² https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(21)00249-8/fulltext

³ World Health Organization (2022). COVID-19 pandemic triggers 25% increase in prevalence of anxiety and depression worldwide. Available at www.who.int/news/item/02-03-2022-covid-19-pandemic-triggers-25-increase-in-prevalence-of-anxiety-and-depression-worldwide.