search
Back to results

Improving Visual Attention in Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active anodal tDCS
Sham tDCS
Sponsored by
The University of Texas at Dallas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas at Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Anodal followed by sham stimulation tDCS to rTPJ

Anodal followed by sham stimulation tDCS to dmPFC

Sham followed by anodal stimulation tDCS to rTPJ

Sham followed by anodal stimulation tDCS to dmPFC

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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.

Full Information

First Posted
March 15, 2019
Last Updated
June 22, 2021
Sponsor
The University of Texas at Dallas
search

1. Study Identification

Unique Protocol Identification Number
NCT03880227
Brief Title
Improving Visual Attention in Schizophrenia
Official Title
Improving Visual Attention to Social Stimuli in Individuals With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2019 (Actual)
Primary Completion Date
March 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Dallas

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal followed by sham stimulation tDCS to rTPJ
Arm Type
Experimental
Arm Description
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.
Arm Title
Anodal followed by sham stimulation tDCS to dmPFC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham followed by anodal stimulation tDCS to rTPJ
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham followed by anodal stimulation tDCS to dmPFC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active anodal tDCS
Intervention Description
active anodal tDCS with behavioral tasks to assess visual attention
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
sham tDCS with behavioral tasks to assess visual attention
Primary Outcome Measure Information:
Title
Visual Attention to Static Faces
Description
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).
Time Frame
Assessment will be completed 30 minutes after completion of the active/sham stimulation
Title
Visual Attention to Dynamic Actor
Description
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).
Time Frame
Assessment will be completed 30 minutes after completion of the active/sham stimulation
Title
Visual Attention to Dynamic Social Scenes
Description
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).
Time Frame
Assessment will be completed 30 minutes after completion of the active/sham stimulation
Secondary Outcome Measure Information:
Title
Fixation Stabilization
Description
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.
Time Frame
Assessment will be completed 30 minutes after completion of the active/sham stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans S Klein, MS
Organizational Affiliation
University of Texas at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Visual Attention in Schizophrenia

We'll reach out to this number within 24 hrs