Placebo control
Research Papers
The Treatment of Autism Spectrum Disorder With Auditory Neurofeedback: A Randomized Placebo Controlled Trial Using the Mente Autism Device
Introduction: Children affected by autism spectrum disorder (ASD) often have impairment of social interaction and demonstrate difficulty with emotional communication, display of posture and facial expression, with recognized relationships between postural control mechanisms and cognitive functions. Beside standard biomedical interventions and psychopharmacological treatments, there is increasing interest in the use of alternative non-invasive treatments such as neurofeedback (NFB) that could potentially modulate brain activity resulting in behavioral modification. Methods: Eighty-three ASD subjects were randomized to an Active group receiving NFB using the Mente device and a Control group using a Sham device. Both groups used the device each morning for 45 minutes over a 12 week home based trial without any other clinical interventions. Pre and Post standard ASD questionnaires, qEEG and posturography were used to measure the effectiveness of the treatment. Results: Thirty-four subjects (17 Active and 17 Control) completed the study. Statistically and substantively significant changes were found in several outcome measures for subjects that received the treatment. Similar changes were not detected in the Control group. Conclusions: Our results show that a short 12 week course of NFB using the Mente Autism device can lead to significant changes in brain activity (qEEG), sensorimotor behavior (posturography), and behavior (standardized questionnaires) in ASD children.
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.
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