An interventional study of transcranial Direct Current Stimulation tDCS in Behaviors and Mental Disorders, sponsored by Hôpital le Vinatier. Withdrawn at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-22.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Basic science
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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Intensity : 1,5mA Duration : 20 minutes stimulation over frontal (F3/F4) electrodes
Device: transcranial Direct Current Stimulation tDCS
Intensity : 1,5mA Duration : 20 minutes stimulation over parietal(CP3 CP4) electrodes
Device: transcranial Direct Current Stimulation tDCS
75 participants will receive 20 minutes of active tDCS (1,5mA, 20 minutes stimulation over frontal (F3/F4) electrodes ); A group of 75 participants will receive 1,5mA 20 minutes of stimulation over parietal (CP3 CP4) electrodes. During this stimulation session and we will also measure your ability to perceive visual and auditory objects presented by a computer, while recording your brain activity using electroencephalography or EEG (a technique using electrodes that measures the electrical activity of your brain)
Causation Task - testing time based causal judgments
Primary metric: threshold defined as the smallest time difference (in 16.7ms increments) at which subject judge ball movement "B" to be caused by the impact of ball "A" 75% of the time.
Time frame: 3 months
Triangle Task - measuring the extent to which temporal coincidence is used to infer causality in a social situation
Primary metric: threshold of tolerated relational time delay (levels in 16.7ms increments) between interacting visual figures (i.e triangles), under which participants reliably (at 75%) perceive social agency or social interactions.
Time frame: 3 months
EEG Task 1, Time visual oddball task - for measuring electrophysiological markers of active temporal (time) deviance detection
Primary metric: Mismatch negativity in the event related potentials of electrodes over the visual cortex with typical latency of 150-250ms after the onset of the deviant stimuli
Time frame: 3 months
EEG Task 2, Covert visual simultaneity task - an exploratory task designed to model the visual Simultaneity behavioral task
Primary metric: Dependent measure: decibel change in Alpha and Beta power across bellow- threshold and above- threshold conditions
Time frame: 3 months
Resting state oscillatory structure
Primary metric: Dependent measure: decibel change in Alpha and Beta power during rest
Time frame: 3 months
This study is withdrawn, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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