Improving Visual Attention in Schizophrenia

NCT03880227 | Completed Results FDA Device

• 1 other identifier: 19-58
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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).

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Fixation Stabilization

  Assessment will be completed 30 minutes after completion of the active/sham stimulation

Study Arms (4)

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.

Device: Active anodal tDCS; Device: Sham tDCS

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.

Device: Active anodal tDCS; Device: Sham tDCS

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.

Device: Active anodal tDCS; Device: Sham tDCS

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.

Device: Active anodal tDCS; Device: Sham tDCS

Interventions

Active anodal tDCS DEVICE

active anodal tDCS with behavioral tasks to assess visual attention

Anodal followed by sham stimulation tDCS to dmPFC; Anodal followed by sham stimulation tDCS to rTPJ; Sham followed by anodal stimulation tDCS to dmPFC; Sham followed by anodal stimulation tDCS to rTPJ

Sham tDCS DEVICE

sham tDCS with behavioral tasks to assess visual attention

Anodal followed by sham stimulation tDCS to dmPFC; Anodal followed by sham stimulation tDCS to rTPJ; Sham followed by anodal stimulation tDCS to dmPFC; Sham followed by anodal stimulation tDCS to rTPJ

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

The University of Texas at Dallas

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Hans Klein
• Organization: The University of Texas at Dallas

hans.klein@utdallas.edu

8304562444

Study Officials

• Hans S Klein, MS

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: March 25, 2019
• Primary Completion: March 4, 2020
• Study Completion: March 4, 2020
• Last Updated: July 13, 2021
• Results First Posted: July 13, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)