controlled clinical trial
Research Papers
Nonpharmacological Treatments for ADHD: A Meta-Analytic Review
Objective: The authors replicated and expanded on Fabiano et al.’s meta-analysis of behavioral treatments for ADHD, systematically comparing the efficacy of 7 nonpharmacological interventions. Method: A total of 14 controlled treatment studies conducted post-1994—evaluating behavior modification, neurofeedback therapy, multimodal psychosocial treatment, school-based programs, working memory training, parent training, and self-monitoring—were identified, primarily by searching electronic English-language databases. The results were meta-analyzed: mean-weighted effect sizes for the treatment outcomes of 625 participants (382 treatment, 243 controls) were calculated, and moderator analyses examined contributions of gender, ADHD subtype, and treatment “dosage” to outcome. Results: Behavior modification and neurofeedback treatments were most supported by this evidence. Interventions were generally more efficacious for girls, and least efficacious for the “combined” ADHD subtype. The authors found no dose or age effects. Conclusion: Based on the small, published literature, this study supports some nonpharmacological interventions for ADHD, and indicates directions for more evaluation research into psychological treatments.
View Full Paper →Effects of Neurofeedback Training on Attention in Children with Intellectual Disability
This study investigated effects of neurofeedback (NFB) training on attention in children with intellectual disability (ID). Twenty-one children with ID were assigned to an NFB training group (n = 7), to a visual perception (VP) training group (n = 7), or to a no-treatment group (n = 7). Two groups received 36 sessions of NFB or VP training, respectively, over 12 weeks. Children's Color Trails Test-2, Stroop Color and Word Test, and Digit Span were administered to all participants before and after training. The follow-up study was conducted with both the NFB and VP groups in the same way after 3 months. The EEGs of the NFB group also were measured. The NFB group showed significantly improved scores on the all tests compared to the 2 control groups. The brainwaves of the frontal lobes of the NFB group declined significantly in theta wave amplitude and theta-to-beta ratio. The NFB results were maintained in the follow-up study. Beta/SMR uptraining seemed to be an effective way to enhance attention in children with ID.
View Full Paper →Treatment of Fibromyalgia Syndrome Using Low-Intensity Neurofeedback with the Flexyx Neurotherapy System: A Randomized Controlled Clinical Trial
Background. Treatment of fibromyalgia syndrome (FMS) remains a clinical challenge. Pain, somatic and cognitive symptoms may be due to neurosensitization involving CNS-activated autonomic and musculoskeletal reactions, associated with EEG abnormalities that may respond to brainwave-based stimulation biofeedback. This study's objective was to examine the efficacy and safety of a novel EEG neurobiofeedback treatment, the Flexyx Neurotherapy System® (FNS), and electrophysiological responses in persons with fibromyalgia. Methods. Arandomized, double-blind, placebo-controlled clinical trial was conducted in two private practices: a free-standing neurobiofeedback center and a rheumatologist's office at an academic medical center. Sixty-four participants with FMS (American College of Rheumatology criteria; Wolfe et al., 1990) for at least three years and symptoms for at least 48 months with no recent remission were randomized to treatment. A total of 22 treatment sessions were administered over at least 11 weeks of active (n = 33) or sham (n = 31) FNS therapy. Primary efficacy measures were the Clinical Global Impressions improvement scores, Clinician (CGI-I) and Participant (PGI-I) versions. Secondary outcomes included dolorimetry and tender point count, questionnaires (fibromyalgia symptom scales, CNS Dysfunction Questionnaire, Fibromyalgia Impact Questionnaire, Symptom Checklist-90-R), and EEG activity (delta, alpha, total amplitude). Results. More participants treated with active FNS than with sham improved partially or fully on the CGI-I at session 22 (p = .01) and follow-up (p = .04). The active FNS group had a higher CGI-I full response rate at session 22 (p < .05) but not at one-week post-treatment (p = .07). Significant active versus sham PGI-I responses were not detected (p>.10). There was no significant treatment effect on any secondary outcome measure and no specific symptom improved preferentially with active compared with sham FNS. The most commonly reported side effect was fatigue/tiredness. Pre-treatment delta/alpha EEG amplitude ratio > 1 was associated with PGI-I (but not CGI-I) response independent of treatment group assignment. Conclusion. FNS monotherapy is insufficient for treating chronic, nonremitting FMS.
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.
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