Behaviors and Mental Disorders Clinical Trial
Official title:
Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia
Social cognition concerns the understanding of how people think about others and how that, in turn, influences our behavior, feelings, and social interactions. schizophrenia social-cognitive impairment is profound (effect size D>1.2), medication resistant and critically limits functional well-being . Social cognition involves complex patterns of coordinated activity within numerous cortical and subcortical networks, making it a difficult target for clinical neuroscience investigation. Yet, prior research demonstrates that sensory-perceptual dysfunction in schizophrenia can upwardly generalize into higher-order social-cognitive impairment making perception a tractable and fruitful approach for studying social cognition in schizophrenia. Here, the investigators explore how distortions in perception of temporal coincidence can contribute to the aberrant inferences of physical causation and social agency.
Social cognitive deficits in these patients are robust and hinder their ability to maintain
gainful employment as well as forge and sustain meaningful social relationships. Current
antipsychotic medications are largely ineffective in treating these symptoms. The proposed
protocol aims at utilizing Noninvasive Brain Stimulation (NIBS) and cognitive behavioral
training to enhance core perceptual impairment in marking time that may contribute to both
social and nonsocial cognitive dysfunction in schizophrenia.
Cognitive behavioral training along the line investigators propose has no reported adverse
effects.The transdirect current stimulation (tDCS) is a very safe method with encouraging
results in previous works in which no severe adverse events where found. There are a few
minor side effects including skin irritation, a phosphene at the start of stimulation,
nausea, headache, dizziness, and itching under the electrode. A recent study of over 500
subjects using the currently accepted protocol reported only a slight skin irritation and a
phosphene as side effects. Patients can benefit from a significant improvement of invalidant
symptoms but also of their quality of life. To ensure safety, patients will be accompanied
throughout the protocol by professionals trained in the management of their disease. Besides
the protocol procedure, patients will be supported, in all centers, according to the
international recommendations in terms of safety and practice. Patients receiving placebo
procedure after randomization will pursue pharmacological treatment and usual health care.
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