clinical trial
Research Papers
Neurofeedback Learning Is Skill Acquisition but Does Not Guarantee Treatment Benefit: Continuous-Time Analysis of Learning-Curves From a Clinical Trial for ADHD
Neurofeedback for attention deficit/hyperactivity disorder (ADHD) has long been studied as an alternative to medication, promising non-invasive treatment with minimal side-effects and sustained outcome. However, debate continues over the efficacy of neurofeedback, partly because existing evidence for efficacy is mixed and often non-specific, with unclear relationships between prognostic variables, patient performance when learning to self-regulate, and treatment outcomes. We report an extensive analysis on the understudied area of neurofeedback learning . Our data comes from a randomised controlled clinical trial in adults with ADHD (registered trial ISRCTN13915109; N = 23; 13:10 female:male; age 25–57). Patients were treated with either theta-beta ratio or sensorimotor-rhythm regimes for 40 one-hour sessions. We classify 11 learners vs 12 non-learners by the significance of random slopes in a linear mixed growth-curve model. We then analyse the predictors, outcomes, and processes of learners vs non-learners, using these groups as mutual controls. Significant predictive relationships were found in anxiety disorder (GAD), dissociative experience (DES), and behavioural inhibition (BIS) scores obtained during screening. Low DES, but high GAD and BIS, predicted positive learning. Patterns of behavioural outcomes from Test Of Variables of Attention, and symptoms from adult ADHD Self-Report Scale, suggested that learning itself is not required for positive outcomes. Finally, the learning process was analysed using structural-equations modelling with continuous-time data, estimating the short-term and sustained impact of each session on learning. A key finding is that our results support the conceptualisation of neurofeedback learning as skill acquisition, and not merely operant conditioning as originally proposed in the literature.
View Full Paper →A 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 →A Randomized Trial of Comparing the Efficacy of Two Neurofeedback Protocols for Treatment of Clinical and Cognitive Symptoms of ADHD: Theta Suppression/Beta Enhancement and Theta Suppression/Alpha Enhancement
Introduction. Neurofeedback (NF) is an adjuvant or alternative therapy for children with Attention Deficit Hyperactivity Disorder (ADHD). This study intended to compare the efficacy of two different NF protocols on clinical and cognitive symptoms of ADHD. Materials and Methods. In this clinical trial, sixty children with ADHD aged 7 to 10 years old were randomly grouped to receive two different NF treatments (theta suppression/beta enhancement protocol and theta suppression/alpha enhancement protocol). Clinical and cognitive assessments were conducted prior to and following the treatment and also after an eight-week follow-up. Results. Both protocols alleviated the symptoms of ADHD in general (p < 0.001), hyperactivity (p < 0.001), inattention (p < 0.001), and omission errors (p < 0.001); however, they did not affect the oppositional and impulsive scales nor commission errors. These effects were maintained after an eight-week intervention-free period. The only significant difference between the two NF protocols was that high-frequency alpha enhancement protocol performed better in suppressing omission errors (p < 0.001). Conclusion. The two NF protocols with theta suppression/beta enhancement and theta suppression/alpha enhancement have considerable and comparable effect on clinical symptoms of ADHD. Alpha enhancement protocol was more effective in suppressing omission errors.
View Full Paper →Clinical Efficacy of a New Automated Hemoencefalographic Neurofeedback Protocol
Among the ongoing attempts to enhance cognitive performance, an emergent and yet underrepresented venue is brought by hemoencefalographic neurofeedback (HEG). This paper presents three related advances in HEG neurofeedback for cognitive enhancement: a) a new HEG protocol for cognitive enhancement, as well as b) the results of independent measures of biological efficacy (EEG brain maps) extracted in three phases, during a one year follow up case study; c) the results of the first controlled clinical trial of HEG, designed to assess the efficacy of the technique for cognitive enhancement of an adult and neurologically intact population. The new protocol was developed in the environment of a software that organizes digital signal algorithms in a flowchart format. Brain maps were produced through 10 brain recordings. The clinical trial used a working memory test as its independent measure of achievement. The main conclusion of this study is that the technique appears to be clinically promising. Approaches to cognitive performance from a metabolic viewpoint should be explored further. However, it is particularly important to note that, to our knowledge, this is the world's first controlled clinical study on the matter and it is still early for an ultimate evaluation of the technique., Entre los intentos en curso para mejorar el rendimiento cognitivo, uno emergente y todavía insuficientemente representado es el neurofeedback hemoencefalográphico (HEG). Este trabajo presenta tres avances relacionados con HEG neurofeedback para la mejora cognitiva: a) un nuevo protocolo HEG para la mejora cognitiva, así como b) los resultados de las medidas independientes de la eficacia biológica (mapas cerebrales EEG) extraídos en tres fases durante un año estudio de seguimiento de casos; c) los resultados del primer ensayo clínico controlado de HEG, diseñado para evaluar la eficacia de la técnica para la mejora cognitiva de población adulta y neurológicamente sana. El nuevo protocolo fue desarrollado en el marco de un software que organiza algoritmos de señales digitales en un formato de diagrama de flujo. Los mapas de cerebro fueron producidos a través de 10 registros cerebrales. El ensayo clínico utilizó un test de memoria de trabajo como medida independiente de sus logros. La principal conclusión de este estudio es que la técnica parece ser clínicamente prometedora. Los enfoques para el rendimiento cognitivo desde un punto de vista metabólico deben investigarse más a fondo. Sin embargo, es particularmente importante tener en cuenta que, a nuestro entender, este es el primer estudio clínico controlado sobre el tema en el mundo, y aún es pronto para una evaluación final de la técnica.
View Full Paper →EEG biofeedback vs. placebo treatment for Attention-Deficit/Hyperactivity Disorder: A pilot study
Method: Seven children diagnosed with attention-deficit hyperactivity disorder (ADHD) were trained using a standard EEG biofeedback treatment protocol designed to alter SMR/theta ratios and reduce behavioral symptomatology diagnostic of ADHD. During alternate periods they were also trained using a placebo protocol that was identical to the treatment protocol, save that the association between EEG patterns and feedback to the participants was random. Single-case design elements were used to control for the effects of internal validity threats such as maturation, history, and treatment order. Two participants failed to complete all training sessions, and the effects of training on behavior were analyzed both including and excluding these non-completers. Results: When all participants were included in analyses that controlled for overall trend, EEG biofeedback was found to be no more effective than the placebo control condition involving non-contingent feedback, and neither procedure resulted in improvements relative to baseline levels. When overall behavioral trends unrelated to training were not controlled for and noncompleters were excluded from the analysis, it could be mistakenly concluded that EEG biofeedback is significantly more effective than placebo and that the effect sizes involved are moderate to large. These results indicate that many previous reports of the efficacy of EEG biofeedback for ADHD, particularly those presenting series of single cases, might well have been based on spurious findings.
View Full Paper →Neurofeedback Treatment for Attention-Deficit/Hyperactivity Disorder in Children: A Comparison with Methylphenidate
Clinical trials have suggested that neurofeedback may be efficient in treating attention-deficit/hyperactivity disorder (ADHD). We compared the effects of a 3-month electroencephalographic feedback program providing reinforcement contingent on the production of cortical sensorimotor rhythm (12–15 Hz) and beta1 activity (15–18 Hz) with stimulant medication. Participants were N = 34 children aged 8–12 years, 22 of which were assigned to the neurofeedback group and 12 to the methylphenidate group according to their parents' preference. Both neurofeedback and methylphenidate were associated with improvements on all subscales of the Test of Variables of Attention, and on the speed and accuracy measures of the d2 Attention Endurance Test. Furthermore, behaviors related to the disorder were rated as significantly reduced in both groups by both teachers and parents on the IOWA-Conners Behavior Rating Scale. These findings suggest that neurofeedback was efficient in improving some of the behavioral concomitants of ADHD in children whose parents favored a nonpharmacological treatment.
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