Back to results

Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia (NSOCOG)

Primary Purpose

Behaviors and Mental Disorders

Status

Withdrawn

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

transcranial Direct Current Stimulation tDCS

About this trial

This is an interventional basic science trial for Behaviors and Mental Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Hopital Le Vinatier

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

transcranial Direct Current Stimulation ( tDCS )

transcranial Direct Current Stimulation ( tDCS)

Arm Description

Intensity : 1,5mA Duration : 20 minutes stimulation over frontal (F3/F4) electrodes

Intensity : 1,5mA Duration : 20 minutes stimulation over parietal(CP3 CP4) electrodes

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

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

Resting state oscillatory structure

Primary metric: Dependent measure: decibel change in Alpha and Beta power during rest

Full Information

NCT ID

NCT03213600

First Posted

July 7, 2017

Last Updated

April 19, 2019

Sponsor

Hôpital le Vinatier

1. Study Identification

Unique Protocol Identification Number

NCT03213600

Brief Title

Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia

Acronym

NSOCOG

Official Title

Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Withdrawn

Why Stopped

One of the investigators went abroad

Study Start Date

November 1, 2018 (Anticipated)

Primary Completion Date

September 1, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hôpital le Vinatier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Behaviors and Mental Disorders

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

The investigators will enroll 150 subjects comprising three population groups SZ, At Risk and HS.) Immediately after inclusion, participants will be randomized into 2 equal groups via random generation of two binary integer's reflecting tDCS-treatment condition or the tDCS control (sham) resulting in random allocation into one of 2 study arms. This randomization will be stratified per population group to insure that both conditions are equally reflected across all three groups.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

transcranial Direct Current Stimulation ( tDCS )

Arm Type

Active Comparator

Arm Description

Intensity : 1,5mA Duration : 20 minutes stimulation over frontal (F3/F4) electrodes

Arm Title

transcranial Direct Current Stimulation ( tDCS)

Arm Type

Sham Comparator

Arm Description

Intensity : 1,5mA Duration : 20 minutes stimulation over parietal(CP3 CP4) electrodes

Intervention Type

Device

Intervention Name(s)

transcranial Direct Current Stimulation tDCS

Intervention Description

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)

Primary Outcome Measure Information:

Title

Causation Task - testing time based causal judgments

Description

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

Title

Triangle Task - measuring the extent to which temporal coincidence is used to infer causality in a social situation

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

EEG Task 1, Time visual oddball task - for measuring electrophysiological markers of active temporal (time) deviance detection

Description

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

Title

EEG Task 2, Covert visual simultaneity task - an exploratory task designed to model the visual Simultaneity behavioral task

Description

Primary metric: Dependent measure: decibel change in Alpha and Beta power across bellow- threshold and above- threshold conditions

Time Frame

3 months

Title

Resting state oscillatory structure

Description

Primary metric: Dependent measure: decibel change in Alpha and Beta power during rest

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

POULET EMMANUEL, MD - PhD

Organizational Affiliation

CH LE VINATIER

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Le Vinatier

City

Bron

ZIP/Postal Code

69678

Country

France

12. IPD Sharing Statement

Learn more about this trial

Neurostimulation-enhanced Behavioral Remediation of Social Cognition in Schizophrenia

We'll reach out to this number within 24 hrs