STIPED: New EU research project to introduce an innovative brain stimulation therapy for children and adolescents with attention-deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD)Chronic mental health disorders significantly reduce the quality of life of the affected children and adolescents, pose strong challenges to their families and come with high societal costs. Despite the available treatment options (pharmacotherapy and behavioural therapy), many children and adolescents do not show sufficient improvement of their symptoms. Considering ADHD and ASD only, the annual overall costs of these mental health disorders are estimated at more than €10,000/patient in Europe, resulting in more than €2 million in lifetime costs/patient. Due to lack of targeted interventions, compliance issues, insufficient effect sizes and a high non-responder rate to currently available interventions, there is an urgent need to develop innovative and new interventions for chronic paediatric neuropsychiatric disorders, such as ADHD and ASD.
The Scientific ApproachThus, this project aims at studying safety, dynamic dose-response relation, underlying mechanisms, and treatment effects of the innovative intervention using transcranial direct-current stimulation (tDCS) in children and adolescents with ADHD and ASD. tDCS has been shown to be an innovative, effective and safe alternative treatment approach for neuropsychiatric disorders in adults. Here, for the first time, the effect of tDCS on core neurocognitive and behavioral outcomes will be proven in children and adolescents. First, effect sizes and safety of standard tDCS in the clinical setting targeting core brain regions and disorder specific cognitive tasks will be established by three phase-IIa randomized, double blind, sham-controlled studies in ADHD and ASD. Second, the impact of brain development and age-dependent anatomical / functional features on effects of tDCS will be studied systematically using methods of modern neurophysiology, neuroimaging and electric current modeling. This involves an additional phase-I clinical trial. Third, mechanisms of tDCS on brain function will be studied, and biomarkers will be developed in order to predict individual response to standard and individualized stimulation protocols. Finally, the applicability of tDCS in children and adolescents will be improved by developing an innovative personalized home-based treatment option in combination with a telemental health service, which will be tested by a fifth, phase-IIa clinical trial. Throughout the entire project, ethical concerns of the target population will be addressed. This project opens a new avenue for the application of tDCS as an alternative treatment for a great number of chronic neuropsychiatric disorders in children and adolescents and will allow flexible integration of tDCS in the daily routine of families. Parents/primary, caregivers/teachers and children wil be involved in the ethical appraisal of this new intervention in order to harmonize the new treatment approach with lifestyles of patients and their families. Additionally, the project will facilitate the integration of a new treatment modality into the clinical care of young patients by transferring treatment protocols to home-based settings, individualization of treatment approach, and establishing telemental health services.
About the ConsortiumIn order to achieve these objectives, a close international collaboration between academic institutions, large clinical centres, and SMEs across Europe will be established. The consortium consists of the following organisations: Christian-Albrechts-University of Kiel (University Hospital of Schleswig-Holstein, Institute of Experimental Medicine, Institute of Medical Informatics and Statistics and Centre for Clinical Trials), Goethe-University Frankfurt am Main, Otto von Guericke University of Magdeburg, University of Coimbra, University of Lisbon, University Hospital of Tours, Center for Integrative Psychiatry of Kiel, Neuroelectric SLU, Starlab Barcelona, ARTTIC.
About Horizon 2020 ProgrammeHorizon 2020 is the biggest EU Research and Innovation programme ever with nearly €80 billion of funding available over 7 years (2014 to 2020). It promises more breakthroughs, discoveries and world-firsts by taking great ideas from the lab to the market. The project is funded as part of the societal challenges pillar in a specific call on new therapies for chronic diseases. Chronic diseases represent a significant burden on individuals and healthcare systems in the European Union and beyond. Innovative and effective therapeutic approaches are required to provide the best quality of care when prevention strategies fail. While considerable basic knowledge has been generated by biomedical research in recent years, the development of new therapies is stagnating, in part due to a lack of clinical validation.
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Phone: +49 431 50030813
Prof. Michael Siniatchkin, Direktor, Institut für Medizinische Psychologie und Medizinische Soziologie,Christian-Albrechts-Universität zu Kiel,Universitätsklinikum Schleswig-Holstein (UKSH)
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STIPED has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 731827.