Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study

Rogel, Ainat; Guez, Jonathan; Getter, Nir; Keha, Eldad; Cohen, Tzlil; Amor, Tali; Todder, Doron

doi:10.1007/s10484-015-9289-6

Cited by 22 publications

(21 citation statements)

References 34 publications

(46 reference statements)

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“…Using active placebo procedures have far less damaging side effects compared to many pharmaceutical interventions. Furthermore, bio/neurofeedback procedures are built on operant conditioning principles, which facilitate active learning techniques that have few, short-lived side effects compared to many long-lived pharmaceutical side effects (Luctkar-Flude, Groll, & Tyerman, 2017;Rogel et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

The fallacy of the placebo-controlled clinical trials: Are positive outcomes the result of ‘indirect’ treatment effects?

Peper

Harvey

2017

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This paper argues that placebo effects have a larger influence on clinical trial outcomes than purported treatment effects, raising questions about the size of effects currently attributed to clinical treatments. Placebo-controlled clinical trials usually do not include an "active" placebo and thus the clinical outcome could be due to the placebo responses to nontherapeutic side effects of the treatment. For this paper, an active placebo includes substances or procedures that permit attribution of a physiological effect such as a B-vitamin that safely causes flushing, or a very low, subtherapeutic dose of a medication, as well as a biofeedback training procedure that safely trains physiological responses other than the target response. The paper also discusses the positive outcome of a sham treatment procedure (e.g., not actually doing the proposed treatment) in contrast to the nocebo effect (e.g., a worse or negative outcome associated with unintended effects of the treatment procedure). This paper emphasizes exercising caution when interpreting results from clinical trials using pharmaceutical or surgical treatments. The paper discusses possible mechanisms underlying the acceptance of treatment procedures which later have been shown to be ineffective or harmful, and highlights the importance of incorporating active placebo procedures to address any covert treatment side effects induced by placebo response. Finally, the authors suggest that clinical trials of bio/neurofeedback treatments carefully consider the important and consequential influences of placebos when designing studies or interpreting the results of trial outcomes.

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Section: Discussionmentioning

confidence: 99%

The fallacy of the placebo-controlled clinical trials: Are positive outcomes the result of ‘indirect’ treatment effects?

Peper

Harvey

2017

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“…The participant will report the worsening of side effects compared to the status prior to the first session. They will report "1" if the side effect worsened or a "0" if there is no change in the symptom (Rogel et al, 2015). All the participants will be asked, "Which condition do you think you received?''…”

Section: Primary Outcomesmentioning

confidence: 99%

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

Mathew

Adhia²,

Smith³

et al. 2020

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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.

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“…In a study of 30 young healthy adults, 70% reported 78 side effects. Most were mild and transient, for example, headaches, fatigue, and mood swings (Rogel et al, 2015). Adverse side effects can be divided into nonspecific, associated with the training in general, and specific, associated with the particular protocol (Matthews, 2007;Ochs, 2007;Rogel et al, 2015).…”

Section: The Effects Of Side Effectsmentioning

confidence: 99%

“…Most were mild and transient, for example, headaches, fatigue, and mood swings (Rogel et al, 2015). Adverse side effects can be divided into nonspecific, associated with the training in general, and specific, associated with the particular protocol (Matthews, 2007;Ochs, 2007;Rogel et al, 2015). Applying inappropriate NFT protocols has been found to be a major cause while certain protocols are more likely to cause specific side effects, for example, increasing power (Hammond & Kirk, 2008;Lubar et al, 1981;Whitsett, Lubar, Holder, Pamplin, & Shabsin, 1982).…”

Section: The Effects Of Side Effectsmentioning

confidence: 99%

Proceedings of the 2016 ISNR Conference: Plenary Presentations

2016

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Participants will learn about diagnosis and intervention. Diagnosis will cover both a brief overview of DSM-5 criteria for both Inattentive and Combined presentations of Attention-Deficit/Hyperactivity Disorder (ADHD) and also mention of comorbidities. An explication of how adding additional measures from single-channel EEG data collection and administration of continuous performance tests supports the diagnosis. The salient areas to be covered during the clinical interview will also be covered; namely, the person's strengths, family matters (with mention of Judith Lubar's use of genograms), social functioning, school and/or work performance, medical factors (allergies, sleep apnea, head injuries, etc.), and extracurricular interests. Data from questionnaires and, for more objective test data, continuous performance tests (Test of Variables of Attention [T.O.V.A.] and Integrated Auditory and Visual Continuous Performance Test [IVA]) will be shown. The various patterns found on single-channel (Cz) EEG assessment will be discussed in the light of the published norms for theta/beta power ratios. EEG patterns (excess theta, excess alpha, spindling beta, all seen with single channel assessment) will be shown. Recent updates on the utility of theta/beta as a marker for ADHD will be shared. Patients who have a diagnosis of ADHD symptoms can vary from children with a relatively simple difficulty with attention span to patients who have a complex array of other difficulties and comorbidities that involve other networks, such as learning disabilities, Asperger's syndrome, autism spectrum disorders, affect disorders, and movement disorders, including Tourette syndrome. This will be acknowledged but not expanded upon in this presentation. Finally, intervention will be discussed with mention of diet, sleep, and exercise but with the main focus being on how to do effective neurofeedback intervention combined with biofeedback with this population. Finally, there will be mention of research that addresses the question of whether neurofeedback can be considered an efficacious treatment for ADHD. References

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Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study

Cited by 22 publications

References 34 publications

The fallacy of the placebo-controlled clinical trials: Are positive outcomes the result of ‘indirect’ treatment effects?

The fallacy of the placebo-controlled clinical trials: Are positive outcomes the result of ‘indirect’ treatment effects?

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

Proceedings of the 2016 ISNR Conference: Plenary Presentations

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