randomized clinical trial
Research Papers
Protocol for a Pilot Randomized Sham-Controlled Clinical Trial Evaluating the Feasibility, Safety, and Acceptability of Infraslow Electroencephalography Neurofeedback Training on Experimental and Clinical Pain Outcomes in People with Chronic Painful Knee
Introduction: Persistent pain is a significant contributor to disability in people living with knee osteoarthritis (KOA). Brain imaging, including electrophysiological studies, confirms altered cortical oscillatory and synchrony patterns in cognitive, affective, and somatosensory areas in individuals with KOA pain. Electroencephalography neurofeedback (EEG-NF) training is a form of neuromodulatory intervention that can help to reduce pain via normalizing dysrhythmic cortical oscillatory patterns that are linked to the pain experience. However, there is a dearth of evidence towards the efficacy of NF in individuals with musculoskeletal pain. Aim: The proposed research is intended to pilot the NF training protocol and assess the feasibility, safety, and acceptability of NF training in individuals with KOA and estimate the variability of experimental and clinical outcome measures following NF training. Design: A parallel, two-armed, double-blind (participant and assessor) pilot randomized sham-controlled clinical trial. Methods: Adults aged 44-75 years with a clinical diagnosis of KOA will be recruited and randomized to either active or sham EEG-NF training. Both groups will receive auditory feedback as a reward for achieving a predetermined activity threshold of the target areas of the brain. Outcome measures include feasibility measures (recruitment, randomization, retention, and dropout rates), acceptability, and adverse events; clinical measures (pain, interference, sleep, mood, and physical activity); and experimental pain outcomes (quantitative sensory testing procedures). Discussion: Outcomes from this study will inform the feasibility and methodology for a future randomized controlled clinical trial.
View Full Paper →Neurofeedback of Slow Cortical Potentials in Children with Attention-Deficit/Hyperactivity Disorder: A Multicenter Randomized Trial Controlling for Unspecific Effects
Background: Neurofeedback (NF) in children with attention-deficit/hyperactivity disorder (ADHD) has been investigated in a series of studies over the last years. Previous studies did not unanimously support NF as a treatment in ADHD. Most studies did not control for unspecific treatment effects and did not demonstrate that self-regulation took place. The present study examined the efficacy of NF in comparison to electromyographic (EMG) feedback to control for unspecific effects of the treatment, and assessed self-regulation of slow cortical potentials (SCPs). Methods: A total of 150 children aged 7–9 years diagnosed with ADHD (82% male; 43% medicated) were randomized to 25 sessions of feedback of SCPs (NF) or feedback of coordination of the supraspinatus muscles (EMG). The primary endpoint was the change in parents’ ratings of ADHD core symptoms 4 weeks after the end of treatment compared to pre-tests. Results: Children in both groups showed reduced ADHD-core symptoms (NF 0.3, 95% CI -0.42 to -0.18; EMG 0.13, 95% CI -0.26 to -0.01). NF showed a significant superiority over EMG (treatment difference 0.17, 95% CI 0.02–0.3, p = 0.02). This yielded an effect size (ES) of d = 0.57 without and 0.40 with baseline observation carried forward (BOCF). The sensitivity analysis confirmed the primary result. Successful self-regulation of brain activity was observed only in NF. As a secondary result teachers reported no superior improvement from NF compared to EMG, but within-group analysis revealed effects of NF on the global ADHD score, inattention, and impulsivity. In contrast, EMG feedback did not result in changes despite more pronounced self-regulation learning. Conclusions: Based on the primary parent-rated outcome NF proved to be superior to a semi-active EMG feedback treatment. The study supports the feasibility and efficacy of NF in a large sample of children with ADHD, based on both specific and unspecific effects. Trial Register: Current controlled trials ISRCTN76187185, registered 5 February 2009.
View Full Paper →A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy
Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large benefit for NF, a well-blinded, sham-controlled RCT is needed to differentiate specific from nonspecific effects. Method: Experts in NF, ADHD, clinical trials, and statistics collaborated to design a double-blind multisite RCT. Results/Conclusion: At four sites, 180 children aged 7 to 10 years with rigorously diagnosed ADHD and TBR ≥ 5 will be randomized to active TBR-NF versus sham NF of equal duration, intensity, and appearance. Sham, utilizing prerecorded EEGs with participant artifacts superimposed, will keep participants and staff blind. Treatment fidelity will be trained/monitored by acknowledged NF leaders. Multidomain assessments before, during, and after treatment (follow-up to 2 years) will also include tests of blinding and sham inertness.
View Full Paper →Neuromodulatory Approaches for Chronic Pain Management: Research Findings and Clinical Implications
Two lines of evidence provide preliminary support for the role that brain state, measured via electroencephalogram (EEG), may play in chronic pain. First, research has identified a link between brain EEG activity and the experience of pain. Second, there are a number of published studies documenting the beneficial effects of interventions that impact the cortical activity associated with chronic pain. These interventions include neurobehavioral treatments such as neurofeedback and hypnosis as well as invasive and non-invasive brain stimulation. Preliminary data showing the efficacy of neuromodulatory strategies for treating pain provides compelling reason to examine how cortical activity (as measured by EEG) may underlie the experience of pain. Existing data already suggest specific approaches that neurofeedback clinicians might consider when treating patients with chronic pain. Reciprocally, observations by neurofeedback practitioners could provide important case data that could foster the design of more definitive randomized clinical trials using such strategies for the treatment of chronic pain.
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