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临床试验/NCT03880227
NCT03880227已完成不适用

Improving Visual Attention to Social Stimuli in Individuals With Schizophrenia

The University of Texas at Dallas1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2019年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Visual Attention to Dynamic Actor

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Active anodal tDCS (Device)

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.

干预措施: Sham tDCS (Device)

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.

干预措施: Active anodal tDCS (Device)

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.

干预措施: Sham tDCS (Device)

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.

干预措施: Active anodal tDCS (Device)

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.

干预措施: Sham tDCS (Device)

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.

干预措施: Active anodal tDCS (Device)

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.

干预措施: Sham tDCS (Device)

结局指标

主要结局

Visual Attention to Dynamic Actor

时间窗: 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).

Visual Attention to Dynamic Social Scenes

时间窗: 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).

Visual Attention to Static Faces

时间窗: 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).

次要结局

  • Fixation Stabilization(Assessment will be completed 30 minutes after completion of the active/sham stimulation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hans Klein

Principal Investigator

The University of Texas at Dallas

研究点 (1)

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