Improving Visual Attention in Schizophrenia

June 22, 2021 updated by: Hans Klein, The University of Texas at Dallas

Improving Visual Attention to Social Stimuli in Individuals With Schizophrenia

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Richardson, Texas, United States, 75080
        • The University of Texas at Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anodal followed by sham stimulation tDCS to rTPJ
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.
active anodal tDCS with behavioral tasks to assess visual attention
sham tDCS with behavioral tasks to assess visual attention
Active Comparator: Anodal followed by sham stimulation tDCS to dmPFC
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.
active anodal tDCS with behavioral tasks to assess visual attention
sham tDCS with behavioral tasks to assess visual attention
Experimental: Sham followed by anodal stimulation tDCS to rTPJ
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.
active anodal tDCS with behavioral tasks to assess visual attention
sham tDCS with behavioral tasks to assess visual attention
Active Comparator: Sham followed by anodal stimulation tDCS to dmPFC
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.
active anodal tDCS with behavioral tasks to assess visual attention
sham tDCS with behavioral tasks to assess visual attention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Assessment will be completed 30 minutes after completion of the active/sham stimulation
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).
Assessment will be completed 30 minutes after completion of the active/sham stimulation
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).
Assessment will be completed 30 minutes after completion of the active/sham stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hans S Klein, MS, University of Texas at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Actual)

March 4, 2020

Study Completion (Actual)

March 4, 2020

Study Registration Dates

First Submitted

March 15, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

June 22, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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