Schizophrenia Clinical Trial
Official title:
Improving Visual Attention to Social Stimuli in Individuals With Schizophrenia
NCT number | NCT03880227 |
Other study ID # | 19-58 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 25, 2019 |
Est. completion date | March 4, 2020 |
Verified date | June 2021 |
Source | The University of Texas at Dallas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study investigates whether visual attention can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).
Status | Completed |
Enrollment | 81 |
Est. completion date | March 4, 2020 |
Est. primary completion date | March 4, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - DSM-IV-TR or DSM-5 diagnosis of schizophrenia or schizoaffective disorder and clinically stable (i.e. no hospitalizations) for at least 8 weeks prior to informed consent and be on a stable medication regimen for at least 6 weeks with no dose changes for a minimum of 2 weeks prior to informed consent. Exclusion Criteria: - The presence or history of a pervasive developmental disorder or mental retardation as defined by a premorbid IQ < 70 - Presence or history of medical or neurological disorders in which neural stimulation would be contraindicated (e.g. presence of epilepsy or history of seizures) - Presence of sensory limitations, including visual or hearing impairments that interfere with assessment - History of electroconvulsive therapy - Not proficient in English - Presence of substance abuse in the past one month or dependence not in remission in the past six months |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas at Dallas | Richardson | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas at Dallas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | Assessment will be completed 30 minutes after completion of the active/sham stimulation | |
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). | 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). | Assessment will be completed 30 minutes after completion of the active/sham stimulation | |
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. | Assessment will be completed 30 minutes after completion of the active/sham stimulation |
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