Improving Visual Attention in Schizophrenia

NCT ID: NCT03880227

Last Updated: 2021-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2020-03-04

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active anodal tDCS

Intervention Type: DEVICE

active anodal tDCS with behavioral tasks to assess visual attention

Sham tDCS

Intervention Type: DEVICE

sham tDCS with behavioral tasks to assess visual attention

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.

Group Type: ACTIVE_COMPARATOR

Active anodal tDCS

Intervention Type: DEVICE

active anodal tDCS with behavioral tasks to assess visual attention

Sham tDCS

Intervention Type: DEVICE

sham tDCS with behavioral tasks to assess visual attention

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.

Group Type: EXPERIMENTAL

Active anodal tDCS

Intervention Type: DEVICE

active anodal tDCS with behavioral tasks to assess visual attention

Sham tDCS

Intervention Type: DEVICE

sham tDCS with behavioral tasks to assess visual attention

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.

Group Type: ACTIVE_COMPARATOR

Active anodal tDCS

Intervention Type: DEVICE

active anodal tDCS with behavioral tasks to assess visual attention

Sham tDCS

Intervention Type: DEVICE

sham tDCS with behavioral tasks to assess visual attention

Interventions

Active anodal tDCS

active anodal tDCS with behavioral tasks to assess visual attention

Intervention Type: DEVICE

Sham tDCS

sham tDCS with behavioral tasks to assess visual attention

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas at Dallas

OTHER

Sponsor Role: lead

Responsible Party

Hans Klein

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans S Klein, MS

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Dallas

Locations

The University of Texas at Dallas

Richardson, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-58

Identifier Type: -

Identifier Source: org_study_id