Supporting Cognitive Control Training With tDCS
2019年9月27日 更新者：Christian Plewnia, MD、University Hospital Tuebingen
Lasting Amelioration of Deficient Cognitive Control by Transcranial Direct Current Stimulation (tDCS)-Enhanced Training
Cognitive control (CC) is an important prerequisite for goal-directed behaviour and often associated with dysfunctional prefrontal activity within the cortex.
This can be ameliorated by non-invasive brain stimulation.
In this randomised single-blind study we compare effects of transcranial direct current stimulation (tDCS) on CC in healthy subjects.
The study includes 162 subjects who undergo a two-week (six sessions) training of cognitive control (adaptive paced auditory serial addition task, PASAT) supported by tDCS.
Subjects are randomised to receive either concurrent anodal, cathodal, or sham tDCS with an intensity of 1 mA or 2 mA of their left (F3) or right (F4) PFC, resulting in eight stimulation groups.
Stimulation effects on performance changes are compared to a sham control group.Changes in Affective state are measured by the positive and negative affect schedule (PANAS), possible transfer effects are assessed by the Eriksen Flanker task.
Stability of effects is measured up to three months after the last intervention.
研究概览
研究类型
介入性
注册 (实际的)
173
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tübingen、德国、72074
- University of Tübingen, Department of Psychiatry and Psychotherapy
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy subjects
- Right-handed (assessed by Edinburgh Handedness Inventory)
- No other concurrent brain stimulation during participation
- Proficient in German (min. CEFR level B)
- Ability to strictly adhere to study timeline
Exclusion Criteria:
- Diagnosed neurological illnesses
- Diagnosed psychiatric disorders
- Achromatopsia
- Metallic implants / tattoos on or near electrode sites
- Consumption of tobacco to an equivalent of ten or more cigarettes per day
- Prior participation in experiments involving the PASAT
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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假比较器：Sham
Sham tDCS (ramp up and ramp down of electrical current before as well as after task performance to elicit physical sensations similar to verum tDCS)
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Added verum or sham tDCS while working on a cognitive control task.
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有源比较器：L1A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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有源比较器：R1A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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有源比较器：L2A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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有源比较器：R2A
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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有源比较器：L1C
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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有源比较器：R1C
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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有源比较器：L2C
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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有源比较器：R2C
Active tDCS
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Added verum or sham tDCS while working on a cognitive control task.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Cognitive performance
大体时间：2 to 14 weeks
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Changes in performance in the PASAT (as assessed by number of correct trials within each PASAT session) due to the various tDCS interventions.
All eight interventions will be compared to the sham group.
Cognitive performance is modified by tDCS, which is applied through a multi-channel stimulator (DC-Stimulator MC, NeuroConn GmbH, Ilmenau, Germany; software version 1.3.8;
two rectangular rubber electrodes (5 x 7 cm)).
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2 to 14 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Affective state
大体时间：2 weeks
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Changes in affective state over the course of the experiment (assessed by the positive and negative affect schedule (PANAS) questionnaire).
Scores are calculated for negative and positive affect separately, by summing up the respective answers.
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2 weeks
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Transfer effect
大体时间：3 weeks
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Transfer effects in the Eriksen Flanker task (assessed through mean reaction times).
Means are calculated for congruent, incongruent, and neutral trials respectively.
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3 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Christian Plewnia, MD、University of Tübingen, Department of Psychiatry and Psychotherapy
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年4月15日
初级完成 (实际的)
2018年3月26日
研究完成 (实际的)
2018年3月26日
研究注册日期
首次提交
2019年9月17日
首先提交符合 QC 标准的
2019年9月27日
首次发布 (实际的)
2019年9月30日
研究记录更新
最后更新发布 (实际的)
2019年9月30日
上次提交的符合 QC 标准的更新
2019年9月27日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.