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STIPED Report Summary

Project ID: 731827
Funded under: H2020-EU.3.1.3.

Periodic Reporting for period 1 - STIPED (Transcranial brain stimulation as innovative therapy for chronic pediatric neuropsychiatric disorder – STIPED)

Reporting period: 2017-01-01 to 2018-06-30

Summary of the context and overall objectives of the project

Chronic paediatric neuropsychiatric disorders (CPND), such as attention-deficit/hyperactivity disorder (ADHD) and autism spectrum disorder (ASD), are highly prevalent and pose a strong challenge to the affected individuals, their families as well as society. Despite several available treatment options, many children and adolescents with ADHD or ASD do not show sufficient improvement with regard to relevant behavioural aspects of the disorders. Thus, additional treatment options are necessary which target specific underlying mechanisms and add new technological approaches, such as safe, innovative transcranial brain stimulation methods. Thus, 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 CPND. TDCS is a non-invasive neuromodulation technique which delivers low-amplitude direct currents to the brain via surface electrodes attached to distinct areas of the scalp. Compared with other treatments, tDCS has a favourable safety-feasibility profile, offers a convincing placebo, can be applied bilaterally, and is portable and inexpensive. According to this aim, the STIPED project 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 as well as to study tolerability of tDCS in children and adolescents with ADHD and ASD (WP4, WP5 and WP9).
- 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). For these purposes, the influence of the effects of tDCS on brain development will be determined.
- To promote a flexible integration of tDCS into the clinical routine and develop a pipeline for tDCS application at home (WP8).
- Based on the better understanding of mechanisms of tDCS, STIPED will establish biomarkers that can help to disentangle the large phenotypic heterogeneity among individuals and to identify biologically homogeneous subgroups or strata of patients that are expected to respond well to tDCS (WP6, WP7).
- To establish a comprehensive framework for both the dissemination and utilization of the STIPED outcomes and technology (WP10).

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the first period of the project (M1-M18), STIPED achieved the following:
- In WP2 (ethics) a qualitative interview study with children and their parents from WP3 and WP4 has been designed, submitted to the ethics committee and been approved. The interviews have been pilot tested and already first interviews have been conducted.
- In WP3 (tDCS in healthy subjects) a preliminary study was performed in order to optimise study design. The study design, methods and protocols have been established, all methods were validated and proven, permissions from national authorities were obtained in every participating center, recruitment of the first subjects was done. Additionally, RegionH and Neuroelectrics have been preparing a preliminary version of an automated pipeline for generating the headmodels for individualized stimulation planning.
- In WP4 (tDCS in ADHD patients) all necessary preconditions to start the clinical trial at the German sites were established (preparation of the protocol, information material, submission to the national authorities and involved ethic committees; development of methods, training of personnel, initiation of most study sites) and to submit to the Portuguese national authorities.
- In WP5 (tDCS in patients with ASD) the preparation of the clinical trial is almost completed as well (the same steps as in WP4), the initiation of the trial will be started very soon.
- In WP6 and WP7 (mechanisms and biomarkers), a variety of novel analytical frameworks were pilot tested and optimally designed to model the individual’s response to tDCS.
- In WP8 (design of a new tDCS device) a pipeline for tDCS application at home was developed. An extensive interaction with academia and the clinical community during workshops, conferences, exhibitions and pitch events has taken place, raising a significant amount of interest on home tDCS use. In the meantime, essential decisions regarding the home system and platform infrastructure were taken, and first functional prototypes for the key solution components was designed.
- In WP9 statistical design, protocols for data monitoring as well as randomization procedures were developed, electronic case report forms for all three clinical trials were established and tested.
- While all this has been achieved within the respective WPs important communication and dissemination efforts have been undertaken in WP10 in the first period of the project. These have included the launch of the website and social media accounts, the preparation of a press release and a project newsletter, the distribution of project flyers, the participation in many international scientific events as well as in local communication events.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Because of the listed objectives the STIPED project has an important impact for the scientific community, the society and the EU. Beside of improvement of treatment quality for ADHD and ASD, the project will achieve the following aims:
- To improve service and increase confidence in compliance support system for disease/patient management, especially for ADHD and ASD.
- To reduce health care costs of CPND.
- To open a new market with a new population of patients, new customers, distribution of stimulation devices in clinics and outpatient departments.
- To increase European competitiveness concerning new innovative treatment techniques.
The project has been raising awareness about neuromodulation in the pediatric population. Most achievements will be open source, therefore, the project provides access to scientific information and developments to the scientific society, medical institutions as well as non-scientific community. All these achievements will increase effectiveness of treatment, reduce direct (through disorders) and indirect (through secondary disability and academic underachievement) costs of CPND. Because the described treatment is applied in the early stages of development, the projects contributes to prevention of future disabilities and improves employment and social integration of affected individuals. Therefore, STIPED provides an important contribution to the mental health in Europe.

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