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This study investigates whether visual attention can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).
Individuals with schizophrenia tend to display abnormal visual attention when performing visual tasks, typically spending less time on salient features of the stimuli (e.g. core facial features or body movement in social tasks), and instead focusing on idiosyncratic features of an image or video. Poor visual attention in schizophrenia has been directly linked to poorer social cognitive performance (e.g. recognizing emotional expressions or social cues) which can impact an individual's day to day functioning.
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 schizophrenia has been demonstrated to improve a wide range of cognitive processes, and in healthy adults, tDCS has been demonstrated to improve aspects of social cognition. TDCS thus appears to be a promising therapeutic technique that may be useful for improving visual attention in patients with schizophrenia, and potentially impact social cognitive performance via an underlying mechanism tying the two. This study will compare visual performance in individuals with schizophrenia across two conditions: active anodal tDCS and sham tDCS, while also comparing between brain stimulation sites: rTPJ and dmPFC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anodal followed by sham stimulation tDCS to rTPJ | Experimental | cross-over design - active stimulation tDCS to the rTPJ followed by behavioral testing. After 1 week washout, sham stimulation tDCS to the rTPJ followed by behavioral testing. |
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| Anodal followed by sham stimulation tDCS to dmPFC | Active Comparator | cross-over design - active stimulation tDCS to the dmPFC followed by behavioral testing. After 1 week washout, sham stimulation tDCS to the dmPFC followed by behavioral testing. |
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| Sham followed by anodal stimulation tDCS to rTPJ | Experimental | cross-over design - sham stimulation tDCS to the rTPJ followed by behavioral testing. After 1 week delay, active stimulation tDCS to the rTPJ followed by behavioral testing. |
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| Sham followed by anodal stimulation tDCS to dmPFC | Active Comparator | cross-over design - sham stimulation tDCS to the dmPFC followed by behavioral testing. After 1 week delay, active stimulation tDCS to the dmPFC followed by behavioral testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active anodal tDCS | Device | active anodal tDCS with behavioral tasks to assess visual attention |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual Attention to Static Faces | Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing static, emotional faces (stimuli: Emotion Recognition - 40). AOIs for static faces will be defined as core facial features (i.e. eyes, nose, mouth). | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
| Visual Attention to Dynamic Actor | Visual attention measured via eye-tracking(percentage of time attending to investigator designated AOIs) when viewing videos of a single actor (stimuli: Bell Lysaker Emotion Recognition Task). AOIs for this task will be defined as core facial features (i.e. eyes, nose, and mouth). | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
| Visual Attention to Dynamic Social Scenes | Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing videos of two or more actors in a scene (stimuli: The Awareness of Social Inference Task Part 3, Version A). AOIs for this task will be defined as salient social and contextual stimuli (e.g. social stimuli are faces of actors, while contextually salient stimuli include items actors are talking about, such as a plate full of food or an empty wallet). | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Fixation Stabilization | Stabilization of visual fixation on fixation circle positioned in middle of screen. Participants will be placed in front of an eyetracking device and asked to keep their eyes focused on a circle in the middle of the screen. Stabilization will be measured via eye-tracking as the deviation from a single point on screen, calculated by assessing the sum of squares of both the x and y axis (output from eyetracking device). Higher number indicates more movement, and thus less stabilization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans S Klein, MS | The University of Texas at Dallas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Dallas | Richardson | Texas | 75080 | United States |
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At enrollment, all participants were matched in pairs based upon key demographic factors (i.e., age, race, gender, and education), and pairs were randomly assigned to stimulation condition, resulting in separate rTPJ and dmPFC stimulation groups. 5 participants did not complete both study visits, with 4 participants not returning to their second visit, and 1 participant discontinuing their first visit prior to stimulation procedures.
81 participants were recruited to the study between March 2019 and March 2020 at a university site in Dallas, TX.
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| ID | Title | Description |
|---|---|---|
| FG000 | Anodal Followed by Sham Stimulation tDCS to rTPJ | Active stimulation tDCS over the rTPJ followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down) After 1 week washout, sham stimulation tDCS to the rTPJ followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes |
| FG001 | Anodal Followed by Sham Stimulation tDCS to dmPFC | Active stimulation tDCS over the dmPFC followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down) After 1 week washout, sham stimulation tDCS to the dmPFC followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes |
| FG002 | Sham Followed by Anodal Stimulation tDCS to rTPJ | Sham stimulation tDCS to the rTPJ followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes After 1 week delay, Active stimulation tDCS over the rTPJ followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down) |
| FG003 | Sham Followed by Anodal Stimulation tDCS to dmPFC | Sham stimulation tDCS to the dmPFC followed by behavioral testing Sham stimulation: pre-programmed sham condition, direct current for 30 seconds, intermittent impedance control checks during the remainder of the 20-minutes After 1 week delay, Active stimulation tDCS over the dmPFC followed by behavioral testing. Active Stimulation: 2mA for 20 minutes (15s ramp up and ramp down) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Visit |
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| 1 Week Washout/ Delay |
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| Second Visit |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anodal/Sham Stimulation tDCS to rTPJ | Within subject design - sham and anodal tDCS to the rTPJ followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention Sham tDCS: sham tDCS with behavioral tasks to assess visual attention |
| BG001 |
| 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, Categorical | Count of Participants |
| 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 | Visual Attention to Static Faces | Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing static, emotional faces (stimuli: Emotion Recognition - 40). AOIs for static faces will be defined as core facial features (i.e. eyes, nose, mouth). | Population analyzed were those that completed both active and sham stimulations (n=5 removed) with valid eyetracking data (n=2 removed) | Posted | Mean | Standard Deviation | proportion of time attending to AOIs | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
|
From time of visit 1 through the follow up phone call (Average time around 10 days, longest duration 29 days)
Routine effects of tDCS were assessed during visit and in follow up phone calls performed after scheduled visits. Definition of adverse events are any events that were beyond these typically reported events.
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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 | Anodal Stimulation tDCS to rTPJ | anodal tDCS to the rTPJ followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | Non-systematic Assessment | participant voluntarily reported experiencing a migraine a few days after sham tDCS visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hans Klein | The University of Texas at Dallas | 8304562444 | hans.klein@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 | Jan 22, 2019 | May 22, 2021 | 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 be paired based on key demographic criteria and assigned to one of two stimulation locations (rTPJ or dmPFC), participants will then complete active and sham stimulation sessions in a randomized, counterbalanced order approximately one week apart.
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| Sham tDCS | Device | sham tDCS with behavioral tasks to assess visual attention |
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| Assessment will be completed 30 minutes after completion of the active/sham stimulation |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Anodal/Sham Stimulation tDCS to dmPFC |
Within subject design - sham and anodal tDCS to the dmPFC followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention Sham tDCS: sham tDCS with behavioral tasks to assess visual attention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Sham tDCS to rTPJ |
sham tDCS to the rTPJ followed by behavioral testing Sham tDCS: sham tDCS with behavioral tasks to assess visual attention |
| OG002 | Anodal Stimulation tDCS to dmPFC | anodal tDCS to the dmPFC followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention |
| OG003 | Sham tDCS to dmPFC | sham tDCS to the dmPFC followed by behavioral testing Sham tDCS: sham tDCS with behavioral tasks to assess visual attention |
|
|
| Primary | Visual Attention to Dynamic Actor | Visual attention measured via eye-tracking(percentage of time attending to investigator designated AOIs) when viewing videos of a single actor (stimuli: Bell Lysaker Emotion Recognition Task). AOIs for this task will be defined as core facial features (i.e. eyes, nose, and mouth). | Population analyzed were those that completed both active and sham stimulations (n=5 removed) with valid eyetracking data (n=2 removed) | Posted | Mean | Standard Deviation | proportion of time attending to AOIs | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
|
|
|
| Primary | Visual Attention to Dynamic Social Scenes | Visual attention measured via eye-tracking (percentage of time attending to investigator designated AOIs) when viewing videos of two or more actors in a scene (stimuli: The Awareness of Social Inference Task Part 3, Version A). AOIs for this task will be defined as salient social and contextual stimuli (e.g. social stimuli are faces of actors, while contextually salient stimuli include items actors are talking about, such as a plate full of food or an empty wallet). | Population analyzed were those that completed both active and sham stimulations (n=5 removed) with valid eyetracking data (n=2 removed) | Posted | Mean | Standard Deviation | proportion of time attending to AOIs | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
|
|
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| Secondary | Fixation Stabilization | Stabilization of visual fixation on fixation circle positioned in middle of screen. Participants will be placed in front of an eyetracking device and asked to keep their eyes focused on a circle in the middle of the screen. Stabilization will be measured via eye-tracking as the deviation from a single point on screen, calculated by assessing the sum of squares of both the x and y axis (output from eyetracking device). Higher number indicates more movement, and thus less stabilization. | Population analyzed were those that completed both active and sham stimulations (n=6 removed) with valid eyetracking data (n=2 removed) | Posted | Mean | Standard Deviation | pixels (equivalent: 1/96th in or 0.26mm) | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
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|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | Sham tDCS to rTPJ | sham tDCS to the rTPJ followed by behavioral testing Sham tDCS: sham tDCS with behavioral tasks to assess visual attention | 0 | 41 | 0 | 41 | 1 | 41 |
| EG002 | Anodal Stimulation tDCS to dmPFC | anodal tDCS to the dmPFC followed by behavioral testing Active anodal tDCS: active anodal tDCS with behavioral tasks to assess visual attention | 0 | 39 | 0 | 39 | 0 | 39 |
| EG003 | Sham tDCS to dmPFC | sham tDCS to the dmPFC followed by behavioral testing Sham tDCS: sham tDCS with behavioral tasks to assess visual attention | 0 | 38 | 0 | 38 | 0 | 38 |
|
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