Among the different neuromodulation techniques, neurofeedback (NF) is gaining increasing interest in the treatment of children with attention-deficit/hyperactivity disorder (ADHD). In this article, a methodological framework is summarised considering the training as a neuro-behavioural treatment. Randomised controlled trials are selectively reviewed. Results from two smaller-scale studies are presented with the first study comprising a tomographic analysis over the course of a slow cortical potential (SCP) training and a correlational analysis of regulation skills and clinical outcome in children with ADHD. In the second study, ADHD-related behaviour was studied in children with tic disorder who either conducted a SCP training or a theta/low-beta (12-15 Hz) training (single-blind, randomised design). Both studies provide further evidence for the specificity of NF effects in ADHD. Based on these findings, a refined model of the mechanisms contributing to the efficacy of SCP training is developed. Despite a number of open questions concerning core mechanisms, moderators and mediators, NF (theta/beta and SCP) training seems to be on its way to become a valuable and ethically acceptable module in the treatment of children with ADHD.

BackgroundResearch in the field of Empirical Ethics (EE) uses a broad variety of empirical methodologies, such as surveys, interviews and observation, developed in disciplines such as sociology, anthropology, and psychology. Whereas these empirical disciplines see themselves as purely descriptive, EE also aims at normative reflection. Currently there is literature about the quality of empirical research in ethics, but little or no reflection on specific methodological aspects that must be considered when conducting interdisciplinary empirical ethics. Furthermore, poor methodology in an EE study results in misleading ethical analyses, evaluations or recommendations. This not only deprives the study of scientific and social value, but also risks ethical misjudgement.DiscussionWhile empirical and normative-ethical research projects have quality criteria in their own right, we focus on the specific quality criteria for EE research. We develop a tentative list of quality criteria – a “road map” – tailored to interdisciplinary research in EE, to guide assessments of research quality. These quality criteria fall into the categories of primary research question, theoretical framework and methods, relevance, interdisciplinary research practice and research ethics and scientific ethos.SummaryEE research is an important and innovative development in bioethics. However, a lack of standards has led to concerns about and even rejection of EE by various scholars. Our suggested orientation list of criteria, presented in the form of reflective questions, cannot be considered definitive, but serves as a tool to provoke systematic reflection during the planning and composition of an EE research study. These criteria need to be tested in different EE research settings and further refined.

Randomization is an internationally accepted methodological tool used to perform sound clinical research. To ensure the clinical value of medical interventions, both evidence based medicine and new drug approvals require that randomized controlled trials (RCT) be conducted. Randomization prevents the manipulation of participant allocation and balances unknown confounders in a way no other method can. The gold standard RCT, however, is complex to conduct and requires significant financial and structural resources. In consequence, drug development and registration are primarily driven by the pharmaceutical industry. Within the field of pediatrics, we need high quality research tailored to children in order to reduce off-label use and to ensure that we expose children only to effective and, above all, safe drug treatments. The American and European regulatory authorities now offer programs to support such studies and clinical researchers and pharmaceutical industries are obliged to put them into practice in the best interest of the children. Issues relating to feasibility as well as ethical issues must be born in mind when planning RCTs in child populations. Obtaining informed assent from children in an adequate manner is one of several key elements. Moreover, it is essential to ensure equipoise before conducting a trial. Thus, issues relating to acceptability can be addressed and the discrimination of treatment groups within RCTs can be prevented. This narrative review addresses ethical and methodological aspects of RCTs in adults and especially in children and includes a quantitative analysis, which explores issues relating to the publication of RCTs.

This preliminary evidence suggests that EGb 761® at a maximal dosage of 240 mg daily might be a clinically useful alternative treatment for children with ADHD, but further evidence is required before firm conclusions can be made.

In the publications analyzed, we found only limited information concerning methods and reflections on ethical principles of the trials. Improvements are thus necessary and possible. We suggest how such trials and their respective publications can be optimized for these aspects.