Lasting Amelioration of Deficient Cognitive Control by Transcranial Direct Current Stimulation (tDCS)-Enhanced Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 2
- 主要终点
- Cognitive performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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)
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
L1A
Active tDCS
- laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
- intensity: of 1 mA
- polarity: anodal
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
R1A
Active tDCS
- laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
- intensity: of 1 mA
- polarity: anodal
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
L2A
Active tDCS
- laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
- intensity: of 2 mA
- polarity: anodal
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
R2A
Active tDCS
- laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
- intensity: of 2 mA
- polarity: anodal
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
L1C
Active tDCS
- laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
- intensity: of 1 mA
- polarity: cathodal
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
R1C
Active tDCS
- laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
- intensity: of 1 mA
- polarity: cathodal
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
L2C
Active tDCS
- laterality: left PFC (F3; second electrode placed on deltoid muscle of the opposing arm)
- intensity: of 2 mA
- polarity: cathodal
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
R2C
Active tDCS
- laterality: right PFC (F4; second electrode placed on deltoid muscle of the opposing arm)
- intensity: of 2 mA
- polarity: cathodal
干预措施: Effect of tDCS on cognitive control task performance (Behavioral)
结局指标
主要结局
Cognitive performance
时间窗: 2 to 14 weeks
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)).
次要结局
- Affective state(2 weeks)
- Transfer effect(3 weeks)
研究者
Christian Plewnia, MD
Doctor of Psychiatry and Psychotherapy
University Hospital Tuebingen