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NCT03880227

Improving Visual Attention in Schizophrenia

Completed NA Results posted Last updated 13 July 2021
What this trial tests

NA trial testing Active anodal tDCS in Schizophrenia in 81 participants. Completed in 4 March 2020.

Timeline
25 March 2019
Primary endpoint
4 March 2020
4 March 2020

Quick facts

Lead sponsorThe University of Texas at Dallas
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposebasic science
Enrollment81
Start date25 March 2019
Primary completion4 March 2020
Estimated completion4 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas at Dallas

Who can join

Adults 18 to 60, any sex, with Schizophrenia or Schizoaffective Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Visual Attention to Static Faces Primary · 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).

GroupValue95% CI
Anodal Stimulation tDCS to rTPJ0.54± 0.15
Sham tDCS to rTPJ0.52± 0.15
Anodal Stimulation tDCS to dmPFC0.57± 0.13
Sham tDCS to dmPFC0.53± 0.14
Visual Attention to Dynamic Actor Primary · 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).

GroupValue95% CI
Anodal Stimulation tDCS to rTPJ0.47± 0.12
Sham tDCS to rTPJ0.46± 0.11
Anodal Stimulation tDCS to dmPFC0.47± 0.11
Sham tDCS to dmPFC0.47± 0.11
Visual Attention to Dynamic Social Scenes Primary · 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).

GroupValue95% CI
Anodal Stimulation tDCS to rTPJ0.22± 0.06
Sham tDCS to rTPJ0.23± 0.07
Anodal Stimulation tDCS to dmPFC0.26± 0.07
Sham tDCS to dmPFC0.25± 0.07
Fixation Stabilization Secondary · 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.

GroupValue95% CI
Anodal Stimulation tDCS to rTPJ0.10± 0.24
Sham tDCS to rTPJ0.08± 0.14
Anodal Stimulation tDCS to dmPFC0.05± 0.10
Sham tDCS to dmPFC0.07± 0.14

Adverse events — posted to ClinicalTrials.gov

Time frame: From time of visit 1 through the follow up phone call (Average time around 10 days, longest duration 29 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Anodal Stimulation tDCS to rTPJ
Serious: 0/38 (0%)
Deaths: 0/38
Sham tDCS to rTPJ
Serious: 0/41 (0%)
Deaths: 0/41
Anodal Stimulation tDCS to dmPFC
Serious: 0/39 (0%)
Deaths: 0/39
Sham tDCS to dmPFC
Serious: 0/38 (0%)
Deaths: 0/38
Other adverse events (1 terms — click to expand)

ReactionSystemAnodal Stimulation tDCS to…Sham tDCS to rTPJAnodal Stimulation tDCS to…Sham tDCS to dmPFC
MigraineNervous system disorders

Data from ClinicalTrials.gov NCT03880227 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Schizophrenia

Currently open trials in the same condition.

Other The University of Texas at Dallas trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03880227.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing