Objectives of STIPED - what we want to do
STIPED has the following objectives:
- To prove effects of tDCS on neurocognitive (working memory, behavioural control, and social cognition) and behavioural (attention, impulsivity, hyperactivity, social withdrawal) impairments and tolerability of tDCS in children and adolescents with ADHD and ASD (WP4 and WP5)
- To identify attitudes and intentions as well as reservations towards the application of tDCS in children, adolescents, their parents, health care providers, and teachers and to investigate the balance between individual benefit and risks of tDCS from an ethical point of view (WP2)
- To Improve the effects of tDCS through optimal, personalized application (WP3, WP6)
- To promote a flexible integration of tDCS into the clinical routine and develop a pipeline for tDCS application at home (WP8)
- To describe mechanisms of tDCS and determine biomarkers (WP6, WP7)
- To establish a comprehensive framework for both the dissemination and utilization of the STIPED outcomes and technology, including training clinical users in the application of the tDCS system (WP10)
STIPED 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 shown to be an effective and safe alternative treatment approach for neuropsychiatric disorders in adults. Here, for the first time, the effect of tDCS on core neurocognitive and behavioural outcomes will be proven in children and adolescents.
Following clinical studies are planned in the framework of the research project.
1) Three phase-IIa randomized, double blind, sham-controlled studies in ADHD and ASD to establish effect sizes and safety of standard tDCS application in the clinical setting targeting core brain regions and disorder specific cognitive tasks.
2) One phase-I clinical trial to study systematically the impact of brain development and age-dependent anatomical / functional features on effects of tDCS using methods of modern neurophysiology, neuroimaging and electric current modeling.
3) 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. The involvement of the children and their families as well as caregivers and teachers in the project will ensure that the new treatment is adapted to the lifestyles of the patients and their families and that their concerns, needs and requirements are adequately considered in the project.