Behaviors and Mental Disorders Clinical Trial
— NSOCOGOfficial title:
Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia
| Verified date | April 2019 |
| Source | Hôpital le Vinatier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | September 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - be between 18 and 45-years-old - have normal hearing assessed by the Five-minute hearing test - have French as a first language - be able to provide written informed consent - be right handed as measured by the Edinburgh handedness scale - covered by, or having the right to Social Security - informed consent signed - patients with diagnosis of schizoprenia or schizoaffective disorder-depressive type as determined by the SCID Diagnostic Interview for DSM-V and administered by a clinician - clinically stable and on a stable medication regiment for the past 3 months Exclusion Criteria: - significant medical or neurological illness or history of fetal alcohol exposure that may increase risks of the study, significantly affect brain function, or impede participation - substance dependence (except nicotine) or abuse not in remission within the past six months or recent use presenting the possibility of acute intoxication or withdrawal - a history of any Axis I psychiatric disorder except those required in the inclusion criteria, any history of pervasive developmental disorder or mental retardation - for Visit 3: If participating in tCDS Contraindications for tDCS (pacemaker or brain stimulator) and/or MRI (neurologic stimulator, pacemaker, cardiac defibrillator, cardiac prosthesis, vascular prosthesis, intracranial clips or clamps, cerebrospinal fluid derivation, metallic splinters in the eyes) - patients under curatorship/guardianship and whose clinical condition requires inpatient procedure under constraint - healthy controls must not be currently using psychoactive médications or have a first-degree relative with a psychotic disorder |
| Country | Name | City | State |
|---|---|---|---|
| France | Hopital Le Vinatier | Bron |
| Lead Sponsor | Collaborator |
|---|---|
| Hôpital le Vinatier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 3 months | |
| Primary | 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. | 3 months | |
| Secondary | 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 | 3 months | |
| Secondary | 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 | 3 months | |
| Secondary | Resting state oscillatory structure | Primary metric: Dependent measure: decibel change in Alpha and Beta power during rest | 3 months |