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临床试验/NCT03814967
NCT03814967已完成不适用

Transcranial Direct Current Stimulation (tDCS) Studies of Behavioral and Electrophysiological (EEG) Correlates of Higher-Order Cognition

University of California, Davis2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
2
主要终点
EEG Correlates of Language and Cognitive Control

研究概览

简要总结

The purpose of this study is to better understand the neural correlates of higher-order cognition, both in the healthy brain and in schizophrenia, and to determine how these mechanisms are modulated by transcranial direct current stimulation (tDCS) at frontal and occipital scalp sites. Testing the effects of tDCS at these scalp sites on cognitive task performance will help us understand the roles of the brain regions corresponding to these sites during higher-order cognitive processing (language comprehension, cognitive control, and related attention and memory processes). Behavioral and electrophysiological (EEG) measures will be used to assess cognitive performance. The investigator's overarching hypothesis is that stimulating prefrontal circuits with tDCS can improve cognitive control performance, and ultimately performance on a range of cognitive tasks, as compared to stimulating a different cortical region (occipital cortex) or using sham stimulation. This study is solely intended as basic research in order to understand brain function in healthy individuals and individuals with schizophrenia. This study is not intended to diagnose, cure or treat schizophrenia or any other disease.

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, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be able to sufficiently speak and understand English so as to be able to understand and complete cognitive tasks.
  • All subjects must have the ability to give valid informed consent.
  • Inclusion Criteria for Patients with Schizophrenia Only:
  • Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder
  • No medication changes in the prior month
  • No medication changes anticipated in the upcoming month
  • Stable outpatient or partial hospital status
  • Normal IQ (>70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test)

排除标准

  • Pacemakers
  • Implanted electrical (brain and spinal) stimulators
  • Implanted defibrillator
  • Metallic implants
  • Skin damage or skin conditions such as eczema at the sites where electrodes will be placed
  • Hair styles hindering the placement of electrodes
  • Cranial pathologies
  • Head trauma
  • Mental retardation
  • Any known history of neurological disorders (including epilepsy, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), stroke, cerebral palsy, any DSM-5 axis I psychiatric disorder (for healthy control subjects), autism)
  • Uncorrected vision problems that would hinder cognitive testing (this also pertains to subjects with color blindness in tasks where discriminating colored objects/items is necessary for successful performance)
  • Pregnancy
  • Substance dependence in the past six months
  • Substance abuse in the past month

结局指标

主要结局

EEG Correlates of Language and Cognitive Control

时间窗: Assessment will begin immediately following stimulation and last for about 1.5 hours.

Electrophysiological data recorded during completion of cognitive control and language comprehension tasks. We will measure oscillatory activity in the theta, alpha, beta and gamma frequency bands.

Behavioral Response (Cognitive Control Task)

时间窗: Assessment will begin immediately following stimulation and last for about 1.5 hours.

We will assess performance on the Dot Pattern Expectancy (DPX) task (error rates and d-prime scores).

Behavioral Response (Language Task)

时间窗: Assessment will begin immediately following stimulation and last for about 1.5 hours.

We will assess performance on a novel Language Comprehension task (accuracy and semantic relatedness judgement scores).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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