NCT03213600

Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hôpital le Vinatier · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Behaviors and Mental Disorders

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-09-01
• Completion: 2019-12-31
• First posted: 2017-07-11
• Last updated: 2019-04-22

Locations

1 site across 1 country: France