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临床试验/NCT03077347
NCT03077347终止不适用

The Effects of Transcranial Direct Current Stimulation on the Neuronal Mechanisms of Cognitive Control in Schizophrenia

University of California, Davis1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Behavioral Response

研究概览

简要总结

The purpose of this study is to better understand the neural correlates of cognitive control (CC) deficits in schizophrenia and determine how these mechanisms can be modulated by transcranial direct current stimulation (tDCS). CC is a critical neurocognitive process that is required for flexible, directed thought and action based on goals and intentions. Identifying and developing paradigms to improve CC is therefore a mental health priority. Current theories of CC postulate that recruitment of the dorsolateral prefrontal cortex (DLPFC) is essential for this process by maintaining high-level information that it can then use to orchestrate patterns of activation in other brain networks to support optimal performance. tDCS is a safe, noninvasive method of modulating regional brain excitability via brief (15-20 m) application of a weak (1-2 mA) current. The goal of the proposed experiments is to combine tDCS with functional magnetic resonance imaging (fMRI) to test the hypotheses that 1) acute tDCS over the DLPFC can improve performance during a CC task (the dot pattern expectancy (DPX) variant of the AX-Continuous Performance Task) in schizophrenia patients and healthy control subjects, and 2) acute tDCS over the DLPFC can increase recruitment of the DLPFC during the DPX. Effects of tDCS on brain functional connectivity (during CC as well as during the resting state) will also be examined, as well as effects on an episodic memory task. The current study will be the first to use functional magnetic resonance imaging (fMRI) to examine the effects of tDCS on the neuronal mechanisms of CC in schizophrenia, and has potentially important implications for therapeutic development for this treatment refractory yet disabling aspect of the illness.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Sufficient English literacy so as to be able to understand and complete cognitive tasks.
  • The ability to give valid informed consent.
  • Diagnosis of schizophrenia, schizophreniform or schizoaffective disorder (for patient group)
  • Stable outpatient or partial hospital status (for patient group)

排除标准

  • Psychiatric medication changes in the prior month (for patient group)
  • No psychiatric medication changes anticipated in the upcoming month (for patient group)
  • Intelligence Quotient (IQ) < 70; IQ will be measured by administering the Wechsler Abbreviated Scale of Intelligence (WASI) test.
  • People under the age of 18
  • Pregnant Women
  • Prisoners
  • Pacemakers
  • Implanted brain stimulators
  • Implanted defibrillator
  • Metallic implants
  • Skin damage or skin conditions such as eczema at the sites where electrodes will be placed
  • Dreadlocks or other hair styles hindering the placement of tDCS electrodes
  • Cranial pathologies
  • Head trauma
  • Mental retardation
  • Neurological disorders
  • 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).
  • Other than nicotine, no subjects reporting substance dependence in the past six months and no substance abuse in the past month

研究组 & 干预措施

Sham Followed by Experimental Stimulation

Other

Sham stimulation administered followed by 24-48 hour washout, then experimental stimulation.

Experimental Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex Placebo Comparator. 1 minute of 2 mA direct current stimulation over the dorsolateral prefrontal cortex followed by 19 minutes of sham stimulation.

干预措施: Transcranial Direct Current Stimulation (Device)

Experimental Stimulation Followed by Sham

Other

Experimental stimulation administered followed by 24-48 hour washout, then sham stimulation.

Experimental Intervention. 20 minutes of 2 mA direct current stimulation over the dorsolateral prefrontal cortex Placebo Comparator. 1 minute of 2 mA direct current stimulation over the dorsolateral prefrontal cortex followed by 19 minutes of sham stimulation.

干预措施: Transcranial Direct Current Stimulation (Device)

结局指标

主要结局

Behavioral Response

时间窗: Assessment will begin immediately following stimulation and last for up to an hour.

Cognitive control-related performance (d-prime context) associated with the task (Dot-Probe Expectancy Task). The d-prime context index was calculated by computing a d-prime index from hits on AX trials and false alarms on BX trials as Z(H) - Z(F), with H representing hits on AX trials, F representing false alarms on BX trials, and Z representing the z-transform of a value. Positive d-prime values indicate more cognitive control, and negative values indicate less cognitive control.

Dorsolateral Prefrontal Cortex Response

时间窗: Assessment will begin immediately following stimulation and last for up to an hour.

Blood oxygen level-dependent response of the dorsolateral prefrontal cortex during a cognitive control task (Dot-Probe Expectancy Task)

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 (1)

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