sham-controlled RCT
Research on sham-controlled rct informs evidence-based practice in neurofeedback and QEEG assessment. Peak Brain Institute stays current with sham-controlled rct findings to ensure our protocols reflect the latest scientific understanding. Explore our 2 research papers covering this topic.
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 →EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial
Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with Diagnostic and Statistical Manual of Mental Disorders (4th ed.; DSM-IV) ADHD were randomized to active NF versus sham-NF and to 2X versus 3X/week treatment frequency. Frequency switch was allowed after Treatment 24. Results: In two school years, 39 participants were recruited and 34 (87%) completed all 40 treatments. Child/parent guesses about assigned treatment were no better than chance. At Treatment 24, 38% chose 2X/week and 62% chose 3X/week. Both active NF and sham yielded large pre–post improvement on parent ratings but NF no more than sham. Conclusion: Blinding appears to work, and sham does not prevent recruitment/retention. Treatment frequency of 3X/week seems preferred over 2X/week and was as effective. A large double-blind RCT is feasible and necessary to test specific NF effectiveness.
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