placebo effect
Research Papers
Neurofeedback impacts cognition and quality of life in pediatric focal epilepsy: An exploratory randomized double-blinded sham-controlled trial
OBJECTIVE: Children with epilepsy experience cognitive deficits and well-being issues that have detrimental effects on their development. Pharmacotherapy is the standard of care in epilepsy; however, few interventions exist to promote cognitive development and to mitigate disease burden. We aimed to examine the impact of two different modalities of neurofeedback (NFB) on cognitive functioning and quality-of-life (QOL) measurements in children and adolescents with controlled focal epilepsy. The study also explored the effects of NFB on clinical outcomes and electroencephalography (EEG) quantitative analysis. METHODS: Participants (n = 44) with controlled focal epilepsy were randomized to one of three arms: sensorimotor rhythm (SMR) NFB (n = 15), slow cortical potentials (SCP) NFB (n = 16), or sham NFB (n = 13). All participants received 25 sessions of intervention. The attention switching task (AST), Liverpool Seizure Severity Scale (LSSS), seizure frequency (SF), EEG power spectrum, and coherence were measured at baseline, postintervention, and at 3-month follow-up. RESULTS: In children and adolescents with controlled focal epilepsy, SMR training significantly reduced reaction time in the AST (p = 0.006), and this was correlated with the difference of change for theta power on EEG (p = 0.03); only the SMR group showed a significant decrease in beta coherence (p = 0.03). All groups exhibited improvement in QOL (p = <0.05). CONCLUSIONS: This study provides the first data on two NFB modalities (SMR and SCP) including cognitive, neurophysiological, and clinical outcomes in pediatric epilepsy. Sensorimotor rhythm NFB improved cognitive functioning, while all the interventions showed improvements in QOL, demonstrating a powerful placebo effect in the sham group.
View Full Paper →Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia
See Thibault et al. (doi:10.1093/awx033) for a scientific commentary on this article.Neurofeedback training builds upon the simple concept of instrumental conditioning, i.e. behaviour that is rewarded is more likely to reoccur, an effect Thorndike referred to as the 'law of effect'. In the case of neurofeedback, information about specific electroencephalographic activity is fed back to the participant who is rewarded whenever the desired electroencephalography pattern is generated. If some kind of hyperarousal needs to be addressed, the neurofeedback community considers sensorimotor rhythm neurofeedback as the gold standard. Earlier treatment approaches using sensorimotor-rhythm neurofeedback indicated that training to increase 12-15 Hz sensorimotor rhythm over the sensorimotor cortex during wakefulness could reduce attention-deficit/hyperactivity disorder and epilepsy symptoms and even improve sleep quality by enhancing sleep spindle activity (lying in the same frequency range). In the present study we sought to critically test whether earlier findings on the positive effect of sensorimotor rhythm neurofeedback on sleep quality and memory could also be replicated in a double-blind placebo-controlled study on 25 patients with insomnia. Patients spent nine polysomnography nights and 12 sessions of neurofeedback and 12 sessions of placebo-feedback training (sham) in our laboratory. Crucially, we found both neurofeedback and placebo feedback to be equally effective as reflected in subjective measures of sleep complaints suggesting that the observed improvements were due to unspecific factors such as experiencing trust and receiving care and empathy from experimenters. In addition, these improvements were not reflected in objective electroencephalographic-derived measures of sleep quality. Furthermore, objective electroencephalographic measures that potentially reflected mechanisms underlying the efficacy of neurofeedback such as spectral electroencephalographic measures and sleep spindle parameters remained unchanged following 12 training sessions. A stratification into 'true' insomnia patients and 'insomnia misperceivers' (subjective, but no objective sleep problems) did not alter the results. Based on this comprehensive and well-controlled study, we conclude that for the treatment of primary insomnia, neurofeedback does not have a specific efficacy beyond unspecific placebo effects. Importantly, we do not find an advantage of neurofeedback over placebo feedback, therefore it cannot be recommended as an alternative to cognitive behavioural therapy for insomnia, the current (non-pharmacological) standard-of-care treatment. In addition, our study may foster a critical discussion that generally questions the effectiveness of neurofeedback, and emphasizes the importance of demonstrating neurofeedback efficacy in other study samples and disorders using truly placebo and double-blind controlled trials.
View Full Paper →Modification of Slow Cortical Potentials in Patients with Refractory Epilepsy: A Controlled Outcome Study
Summary: Purpose: To compare self-regulation of low-frequency EEG components (slow cortical potentials, SCPs) with other methods of seizure control for patients with drug-refractory partial epilepsy and to separate the real anticonvulsive effect from placebo effects. Methods: Results of a treatment program of SCP self-regulation (experimental group) are compared with two groups of patients, one of which learned self-control of respiratory parameters (end-tidal CO2 and respiration rate: RES group); the other received medication with new anticonvulsive drugs (AEDs) in combination with psychosocial counseling (MED group). Clinical, cognitive, behavioral, and personality measures were assessed before and after treatment. In addition, to control for placebo responses, patients repeatedly estimated their beliefs in the efficiency of the respective treatment, their satisfaction and expectations, and the quality of the relationship with their therapists. Results: SCP and MED groups showed a significant decrease of seizure frequency, but the RES group did not. Clear positive changes in the sociopsychological adjustment were obtained in all three groups, with the maximal improvement being attained in the RES group. Conclusions: All kinds of therapy result in considerable improvement of patients' emotional state, which may in part be due to potential placebo effects; however, this improvement is not related to the quality of the therapeutic effect proper (i.e., seizure reduction). Traditional double-blind control group designs are inappropriate for behavioral interventions or treatments with psychoactive pharmacologic drugs. Rather, specific tests can be developed to control the placebo effect and to separate it from the genuine therapeutic effects.
View Full Paper →Alpha wave biofeedback training therapy in alcoholics
This investigation evaluated the therapeutic efficacy of alpha-wave biofeedback treatment for alcoholics. Twenty-five Ss were compared to a matched control group before and after administration of a 3-week alpha-wave biofeedback regimen on a wide variety of criteria that included State-Trait Anxiety, the MMPI, Multiple Affect Adjective Check List, Zuckerman's Sensation Seeking Scale, Watson's Anhedonia Scale, the Brief Psychiatric Rating Scale, and baseline alpha. The experimental Ss received 10 hour-long alpha training sessions. The experimentals showed more improvement than did controls on alpha production and two anxiety measures. Contradictory results appeared on two suspicion/paranoia measures. Alpha training appeared useful in the treatment of anxiety, but not other problems. However, the absence of significant correlations between amount of change on alpha and the anxiety measures suggests that the improvement may be due to a placebo effect.
View Full Paper →EEG feedback training in the treatment of epilepsy: Some questions and some answers
A basic question in EEG feedback training of epileptic patients is whether the decrease in seizures is specifically due to the training or to other factors. Questions may also be raised as to what EEG changes are involved. Preliminary results in five patients suggest that seizure reductions can occur with training which are not due to placebo or nonspecific effects or to changes in medication compliance. These changes occurred rapidly during EEG-contingent feedback training but not when feedback was random in relation to the EEG. Reliable changes in the EEG were also observed, but the question of which mechanism accounts for these results has yet to be answered.
View Full Paper →Kontrolliertes EEG-Alpha-Feedback-Training bei Gesunden und Kopfschmerzpatientinnen
Headache patients and healthy controls underwent alpha-EEG feedback training in 12 sessions. The present study does not support the literature which reports alpha increase by feedback training. The study included a patient group receiving feedback, a patient control group receiving pseudofeedback, and a volunteer group receiving feedback. Increase of alpha EEG was observed under feedback and pseudofeedback. However, there was always more alpha during baseline times than during training times. Alpha increase over time is suggested to be a habituation effect. Headache pain decreased with training (within the boundaries of a placebo effect), and there was no difference in headache decrease between feed-back and pseudofeedback patients.
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