research design
Research Papers
Showing 6 of 8A systematic review of fMRI neurofeedback reporting and effects in clinical populations
Real-time fMRI-based neurofeedback is a relatively young field with a potential to impact the currently available treatments of various disorders. In order to evaluate the evidence of clinical benefits and investigate how consistently studies report their methods and results, an exhaustive search of fMRI neurofeedback studies in clinical populations was performed. Reporting was evaluated using a limited number of Consensus on the reporting and experimental design of clinical and cognitive-behavioral neurofeedback studies (CRED-NF checklist) items, which was, together with a statistical power and sensitivity calculation, used to also evaluate the existing evidence of the neurofeedback benefits on clinical measures. The 62 found studies investigated regulation abilities and/or clinical benefits in a wide range of disorders, but with small sample sizes and were therefore unable to detect small effects. Most points from the CRED-NF checklist were adequately reported by the majority of the studies, but some improvements are suggested for the reporting of group comparisons and relations between regulation success and clinical benefits. To establish fMRI neurofeedback as a clinical tool, more emphasis should be placed in the future on using larger sample sizes determined through a priori power calculations and standardization of procedures and reporting.
View Full Paper →Current practices in clinical neurofeedback with functional MRI-Analysis of a survey using the TIDieR checklist
BACKGROUND: A core principle of creating a scientific evidence base is that results can be replicated in independent experiments and in health intervention research. The TIDieR (Template for Intervention Description and Replication) checklist has been developed to aid in summarising key items needed when reporting clinical trials and other well designed evaluations of complex interventions in order that findings can be replicated or built on reliably. Neurofeedback (NF) using functional MRI (fMRI) is a multicomponent intervention that should be considered a complex intervention. The TIDieR checklist (with minor modification to increase applicability in this context) was distributed to NF researchers as a survey of current practice in the design and conduct of clinical studies. The aim was to document practice and convergence between research groups, highlighting areas for discussion and providing a basis for recommendations for harmonisation and standardisation. METHODS: The TIDieR checklist was interpreted and expanded (21 questions) to make it applicable to neurofeedback research studies. Using the web-based Bristol Online Survey (BOS) tool, the revised checklist was disseminated to researchers in the BRAINTRAIN European research collaborative network (supported by the European Commission) and others in the fMRI-neurofeedback community. RESULTS: There were 16 responses to the survey. Responses were reported under eight main headings which covered the six domains of the TIDieR checklist: What, Why, When, How, Where and Who. CONCLUSIONS: This piece of work provides encouraging insight into the ability to be able to map neuroimaging interventions to a structured framework for reporting purposes. Regardless of the considerable variability of design components, all studies could be described in standard terms of diagnostic groups, dose/duration, targeted areas/signals, and psychological strategies and learning models. Recommendations are made which include providing detailed rationale of intervention design in study protocols.
View Full Paper →Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia
See Thibault et al. (doi:10.1093/awx033) for a scientific commentary on this article.Neurofeedback training builds upon the simple concept of instrumental conditioning, i.e. behaviour that is rewarded is more likely to reoccur, an effect Thorndike referred to as the 'law of effect'. In the case of neurofeedback, information about specific electroencephalographic activity is fed back to the participant who is rewarded whenever the desired electroencephalography pattern is generated. If some kind of hyperarousal needs to be addressed, the neurofeedback community considers sensorimotor rhythm neurofeedback as the gold standard. Earlier treatment approaches using sensorimotor-rhythm neurofeedback indicated that training to increase 12-15 Hz sensorimotor rhythm over the sensorimotor cortex during wakefulness could reduce attention-deficit/hyperactivity disorder and epilepsy symptoms and even improve sleep quality by enhancing sleep spindle activity (lying in the same frequency range). In the present study we sought to critically test whether earlier findings on the positive effect of sensorimotor rhythm neurofeedback on sleep quality and memory could also be replicated in a double-blind placebo-controlled study on 25 patients with insomnia. Patients spent nine polysomnography nights and 12 sessions of neurofeedback and 12 sessions of placebo-feedback training (sham) in our laboratory. Crucially, we found both neurofeedback and placebo feedback to be equally effective as reflected in subjective measures of sleep complaints suggesting that the observed improvements were due to unspecific factors such as experiencing trust and receiving care and empathy from experimenters. In addition, these improvements were not reflected in objective electroencephalographic-derived measures of sleep quality. Furthermore, objective electroencephalographic measures that potentially reflected mechanisms underlying the efficacy of neurofeedback such as spectral electroencephalographic measures and sleep spindle parameters remained unchanged following 12 training sessions. A stratification into 'true' insomnia patients and 'insomnia misperceivers' (subjective, but no objective sleep problems) did not alter the results. Based on this comprehensive and well-controlled study, we conclude that for the treatment of primary insomnia, neurofeedback does not have a specific efficacy beyond unspecific placebo effects. Importantly, we do not find an advantage of neurofeedback over placebo feedback, therefore it cannot be recommended as an alternative to cognitive behavioural therapy for insomnia, the current (non-pharmacological) standard-of-care treatment. In addition, our study may foster a critical discussion that generally questions the effectiveness of neurofeedback, and emphasizes the importance of demonstrating neurofeedback efficacy in other study samples and disorders using truly placebo and double-blind controlled trials.
View Full Paper →Frontal EEG Asymmetry of Mood: A Mini-Review
The present mini-review was aimed at exploring the frontal EEG asymmetry of mood. With respect to emotion, interpreted as a discrete affective process, mood is more controllable, more nebulous, and more related to mind/cognition; in addition, causes are less well-defined than those eliciting emotion. Therefore, firstly, the rational for the distinction between emotion and mood was provided. Then, the main frontal EEG asymmetry models were presented, such as the motivational approach/withdrawal, valence/arousal, capability, and inhibition asymmetric models. Afterward, the frontal EEG asymmetry of mood was investigated following three research lines, that is considering studies involving different mood induction procedures, dispositional mood (positive and negative affect), and mood alterations in both healthy and clinical populations. In general, results were found to be contradictory, no model is unequivocally supported regardless the research line considered. Different methodological issues were raised, such as: the composition of samples used across studies, in particular, gender and age were found to be critical variables that should be better addressed in future studies; the importance of third variables that might mediate the relationship between frontal EEG asymmetries and mood, for example bodily states and hormonal responses; the role of cognition, namely the interplay between mood and executive functions. In light of these issues, future research directions were proposed. Amongst others, the need to explore the neural connectivity that underpins EEG asymmetries, and the need to include both positive and negative mood conditions in the experimental designs have been highlighted.
View Full Paper →NIRS-based neurofeedback training in a virtual reality classroom for children with attention-deficit/hyperactivity disorder: study protocol for a randomized controlled trial
BACKGROUND: Children with attention-deficit/hyperactivity disorder (ADHD) suffer from attention deficits, motor hyperactivity, and impulsive behaviour. These impairments are experienced at home, at school, and with friends. Functional imaging studies show that ADHD behaviour and impairments in executive functions (EFs) are mirrored by aberrant neurophysiological functioning. Moreover, several studies show that ADHD behaviour, impairments in EFs, and a lack of self-control contribute to poor school performance. Non-pharmacological interventions such as neurofeedback training (NFT), for instance, aim at improving neurophysiological and neuropsychological functioning as well as behaviour. Consequently, NFT is expected to improve school performance, EFs, and self-control in children with ADHD. Generalization of acquired self-regulation skills from laboratory to real life is crucial for a transfer to everyday situations and is hypothesized to be facilitated via training using virtual reality (VR) environments. Consequently, experiencing NFT in VR is expected to yield greater effects than training in two dimensions (2D). METHODS/DESIGN: Ninety children with a clinical diagnosis of ADHD will be included in the study. Participants may be medicated or unmedicated. After random assignation to one of three conditions, all participants receive 15 training sessions of either near-infrared spectroscopy (NIRS)-based NFT in VR, NIRS-based NFT in 2D, or electromyogram-based biofeedback training in VR. ADHD symptoms, self-control, EF, health-related quality of life, school performance, and motor activity measured via parent, teacher, and child reports or objectively will be assessed before and after the intervention and at a 6 months follow-up. Furthermore, we are interested in parents' expectations about the training's effects. DISCUSSION: This is, to our knowledge, the first study investigating the efficacy of NFT for children with ADHD in a VR compared to a 2D environment. Furthermore, this study will contribute to the discussion about the efficacy and specific and unspecific effects of NFTs in children with ADHD. In addition to commonly assessed variables such as ADHD symptoms, NIRS and behavioural data obtained in EF measures, health-related quality of life, and parents' expectations about the intervention's effects, this study will investigate the effects on self-control, school performance, and motor activity. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02572180 . Registered on 19 November 2015.
View Full Paper →The pharmacological and non-pharmacological treatment of attention deficit hyperactivity disorder in children and adolescents: protocol for a systematic review and network meta-analysis of randomized controlled trials
BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders of children and adolescents, with a significant impact on health services and the community in terms of economic and social burdens. The objective of this systematic review will be to evaluate the comparative efficacy and safety of pharmacological and non-pharmacological treatments in children and adolescents with ADHD. METHODS: Searches involving PubMed/MEDLINE and the Cochrane Database of Systematic Reviews will be used to identify related systematic reviews and relevant randomized trials. Search results will be supplemented by reports from the regulatory and health technology agencies, clinical trials registers and by data requested from trialists and/or pharmaceutical companies. We will consider studies evaluating pharmacological interventions (e.g. stimulants, non-stimulants, antidepressants), psychological interventions (e.g. behavioural interventions, cognitive training and neurofeedback) and complementary and alternative medicine interventions (e.g. dietary interventions, supplement with fatty acids, vitamins, minerals, aminoacids, herbal treatment, homeopathy, and mind-body interventions including massage, chiropractic, acupuncture, yoga, meditation, Tai chi). Eligible control conditions will be placebo, waitlist, no treatment and usual care. Randomized controlled trials of a minimum of 3 weeks duration will be included. The primary outcomes of interest will be the proportion of patients who responded to treatment and who dropped out of the allocated treatment, respectively. Secondary outcomes will include treatment discontinuation due to adverse events, as well as the occurrences of serious adverse events and specific adverse events (decreased weight, anorexia, insomnia and sleep disturbances, anxiety, syncope and cardiovascular events). Two reviewers will independently screen references identified by the literature search, as well as potentially relevant full-text articles in duplicate. Data will be abstracted and risk of bias will be appraised by two team members independently. Conflicts at all levels of screening and abstraction will be resolved through discussion. Random-effects pairwise meta-analyses and Bayesian network meta-analyses will be conducted where appropriate. DISCUSSION: This systematic review and network meta-analysis will compare the efficacy and safety of treatments used for ADHD in children and adolescents. The findings will assist patients, clinicians and healthcare providers to make evidence-based decisions regarding treatment selection. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42014015008 .
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