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Improving Visual Attention in Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880227
Recruitment Status : Enrolling by invitation
First Posted : March 19, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Hans Klein, The University of Texas at Dallas

Brief Summary:
This study investigates whether visual attention can be improved in individuals with schizophrenia by stimulating the brain via transcranial Direct Current Stimulation (tDCS).

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Device: Active anodal tDCS Device: Sham tDCS Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Improving Visual Attention to Social Stimuli in Individuals With Schizophrenia
Actual Study Start Date : March 25, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: anodal stimulation tDCS to rTPJ
anodal tDCS to the rTPJ followed by behavioral testing
Device: Active anodal tDCS
active anodal tDCS with behavioral tasks to assess visual attention

Sham Comparator: sham tDCS to rTPJ
sham tDCS to the rTPJ followed by behavioral testing
Device: Sham tDCS
sham tDCS with behavioral tasks to assess visual attention

Experimental: anodal stimulation tDCS to dmPFC
anodal tDCS to the dmPFC followed by behavioral testing
Device: Active anodal tDCS
active anodal tDCS with behavioral tasks to assess visual attention

Sham Comparator: sham tDCS to dmPFC
sham tDCS to the dmPFC followed by behavioral testing
Device: Sham tDCS
sham tDCS with behavioral tasks to assess visual attention




Primary Outcome Measures :
  1. Visual attention to static faces [ Time Frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation ]
    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).

  2. Visual attention to dynamic actor [ Time Frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation ]
    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).

  3. Visual attention to dynamic social scenes [ Time Frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation ]
    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).


Secondary Outcome Measures :
  1. Fixation stabilization [ Time Frame: Assessment will be completed 30 minutes after completion of the active/sham stimulation ]
    Stabilization of visual fixation on fixation circle positioned in middle of screen. Stabilization will be measured via eye-tracking and defined as average scanpath length with increased scanpath indicating less stable fixation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880227


Locations
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United States, Texas
The University of Texas at Dallas
Richardson, Texas, United States, 75080
Sponsors and Collaborators
The University of Texas at Dallas
Investigators
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Principal Investigator: Hans S Klein, MS University of Texas at Dallas
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Responsible Party: Hans Klein, Principal Investigator, The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT03880227    
Other Study ID Numbers: 19-58
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders