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临床试验/NCT01602276
NCT01602276终止不适用

The Effect of Transcranial Direct Current Stimulation on Subcortical Brain Functioning

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2012年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Improvement in motor functioning

研究概览

简要总结

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain abilities related to cognition, emotion and/or physical functioning in individuals with subcortical brain damage.

详细描述

While cortical brain structures are thought to be responsible for higher level cognitive functioning (i.e., perception, thoughts, language, memory, attention, and processing), subcortical brain regions (i.e., amygdala, midbrain, hippocampus, and thalamus) are generally believed to be responsible for more fundamental bases of such functions. A significant fraction of the population suffer from disabling disorders and diseases (i.e., Parkinson's disease, subcortical dementia, hypoxic brain damage) that affect subcortical areas. Despite their prevalence, very little success has been achieved in treating such impairments effectively.

This study has two main goals. One is to examine the effect of stimulation on a variety of subcortical functions (i.e., level of alertness, mood, cognition, and motor responding). A second goal is to examine the effects of varying some of the stimulus parameters of tDCS, notably the placement of the electrodes and the duration and frequency of application of current.

Adult participants with a confirmed diagnosis of subcortical brain damage, as well as healthy adults will be randomly assigned to anodal and cathodal stimulation in a counterbalanced order, and both will engage in simple behavioral tasks and/or physiological monitoring. These tasks will be specific to the deficit of interest.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fluent in the English language
  • History of subcortical brain damage (patient group only)
  • No known neurological or cognitive impairment (control group only)

排除标准

  • Appreciable deficits in hearing
  • Schizophrenia, bipolar disorder, or major depression (normal controls only)
  • Any neurological disorder associated with cognitive impairment or neuroanatomic abnormality (normal controls only)
  • Language-based learning disorder (normal controls only)
  • Dementia or Mini-Mental State Exam <24 for normal control participants
  • Any implanted metal device (precludes use of tDCS)
  • Any implanted cardiac pacemaker

研究组 & 干预措施

Active Stimulation

Experimental

Transcranial direct current stimulation using Anodal or Cathodal stimulation over the area of interest

干预措施: Transcranial Direct Current Stimulation (tDCS) (Procedure)

Sham Stimulation

Sham Comparator

Transcranial direct current stimulation (tDCS) that is ramped up and ramped down providing the sensation of tDCS without delivering the full amount of tDCS.

干预措施: Transcranial Direct Current Stimulation (tDCS) (Procedure)

结局指标

主要结局

Improvement in motor functioning

时间窗: 1 month

Improvement in level of consciousness and alertness

时间窗: 1 month

Improvement in cognitive functioning

时间窗: 1 month

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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