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This study investigates whether Introspective Accuracy (IA) can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).
Self-awareness is markedly impaired in severe mental illness including schizophrenia and schizoaffective disorder. This impairment spans awareness of symptoms as well as deficits in the estimation of abilities and capabilities, which we refer to as introspective accuracy (IA). Recent work has provided evidence of IA deficits in schizophrenia spectrum disorders, specifically in the abilities to retrospectively judge everyday functioning and neurocognitive impairment, as well as the ability to make correct real-time judgments of performance on neurocognitive tests.
Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric disorders. TDCS in healthy adults has been demonstrated to improve cognitive and memory performance, and in schizophrenia, tDCS has been found to improve emotion recognition ability. TDCS thus appears to be a promising therapeutic technique that may be useful for improving IA. This study will compare IA performance in individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active anodal tDCS first, then Sham tDCS | Experimental | Active anodal tDCS (20 minutes) followed by behavioral testing; Washout (1 week); sham stimulation (20 minutes) followed by behavioral testing Intervention: Device: active anodal tDCS and sham tDCS |
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| Sham tDCS first, then Active anodal tDCS | Sham Comparator | Sham tDCS (20 minutes) followed by behavioral testing; Washout (1 week); Active anodal tDCS (20 minutes) followed by behavioral testing Intervention: Device: sham tDCS and sham tDCS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| active anodal tDCS | Device | active anodal tDCS with behavioral tasks to assess IA |
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| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation | Neurocognitive Introspective Accuracy (IA) was assessed with the Wisconsin Card Sorting Task after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA. | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation | Social Cognitive Introspective Accuracy assessed with the Penn Emotion Recognition Task (ER40) after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA. | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Pinkham, PhD | The University of Texas at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Unversity of Texas at Dallas | Richardson | Texas | 75080 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Anodal tDCS First, Then Sham Stimulation | Active anodal tDCS followed by behavioral testing; Washout (1 week); Sham stimulation followed by behavioral testing Intervention: Device: active anodal tDCS |
| FG001 | Sham tDCS First, Then Active Stimulation | Sham tDCS followed by behavioral testing; Washout (1 week); Active Stimulation followed by behavioral testing Intervention: Device: sham tDCS |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Anodal tDCS First, Then Sham Stimulation | Active anodal tDCS followed by behavioral testing; Washout (1 week); Sham tDCS followed by behavioral testing Intervention: Device: active anodal tDCS |
| BG001 | Sham tDCS First, Then Active Stimulation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neurocognitive Introspective Accuracy for Active vs. Sham Stimulation | Neurocognitive Introspective Accuracy (IA) was assessed with the Wisconsin Card Sorting Task after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA. | Posted | Mean | Standard Deviation | score on a scale | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
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3 days after each arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Anodal tDCS | 20 minutes of Active anodal tDCS followed by behavioral testing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Pinkham | The University of Texas at Dallas | (972) 883-4462 | amy.pinkham@utdallas.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2017 | Mar 23, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Participants will complete active and sham simulation sessions in a randomized, counterbalanced order approximately one week apart.
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| sham tDCS | Device | sham tDCS with behavioral tasks to assess IA |
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Sham tDCS followed by behavioral testing; Washout (1 week); Active tDCS followed by behavioral testing Intervention: Device: sham tDCS sham tDCS: sham tDCS with behavioral tasks to assess IA |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Mean | Standard Deviation | years |
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| Estimated IQ | Mean | Standard Deviation | units on a scale |
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| Secondary | Social Cognitive Introspective Accuracy for Active vs. Sham Stimulation | Social Cognitive Introspective Accuracy assessed with the Penn Emotion Recognition Task (ER40) after both Active and Sham stimulation. The area under a type 2 ROC (receiver operating characteristic) curve was used to index IA. Values range from .5-1, with higher values indicating better IA. | Posted | Mean | Standard Deviation | score on a scale | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Sham tDCS | 20 minutes of Sham tDCS followed by behavioral testing | 0 | 41 | 0 | 41 | 0 | 41 |
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