Effects of Repetitive tDCS on ad Libitum Smoking Behavior: An EMA and EEG Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Mean number of cigarettes a day at 3 months follow up
研究概览
简要总结
Bilateral (left cathodal/ right anodal) transcranial Direct Current Stimulation (tDCS) over the dorsolateral prefrontal cortex (DLPFC) seems to reduce craving and to increase the time till smoking the first cigarette after the intervention. The current study explores whether actual cigarette consumption decreases after repetitive tDCS. Cigarette consumption and craving will therefore be measured by means of EMA, before (at baseline), during and after multiple tDCS sessions, and at 3 months follow-up.
To study the working mechanism behind the effects of tDCS, electrophysiological responses (ERPs) and behavioral measures of cognitive control functioning will be taken into account at baseline, one day after the last tDCS session and at three months follow up.
We hypothesize that cigarette consumption will decrease after repetitive tDCS, and that this effect is associated with better cognitive control functioning.
详细描述
The proposed experiment is a double-blind randomized placebo-controlled trial. 60 smokers will be randomly assigned to two conditions, namely tDCS or sham (placebo).
Participants will receive real tDCS or sham for three days in one week. The interventions contain twice daily sessions for 13 minutes with an interval of 20 min. Moreover, on the first treatment day and the day after the treatment week, participants complete a number of questionnaires, and perform two psychological tasks (a gambling task and the Go/NoGo task) to measure cognitive control functioning (e.g. risky decision making and inhibitory control respectively). During these tasks, event-related potentials will be recorded by means of EEG. After three months, participants are asked to return to fill out the same questionnaires and perform the same psychological tasks as before, to measure the lasting effect of tDCS. During this last session, event-related potentials will also be recorded. In addition, carbon monoxide levels will be measured on all days where subjects perform the tasks.
EMA:
For three weeks, starting the week before tDCS treatment, participants are asked to log every cigarette before they smoke one. During these weeks, participants complete EMA questionnaires on their mobile phone about cigarette consumption, craving, and affect that will take approximately 5 minutes. The EMA questionnaire will be presented four times daily on a quasi-random basis. Finally, during end-of-day assessments participants have the possibility to indicate any missed cigarettes. At three months follow-up, participants are asked to undergo the same EMA procedure for one more week, to study the lasting effects of tDCS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Currently smoking 10 or more cigarettes a day
- •The ability to speak, read, and write in Dutch at an eight-grade literacy level
排除标准
- •The current abuse of a substance other than nicotine or caffeine
- •History of neurological or psychiatric disorders
- •Any contraindication for electrical brain stimulation procedures such as electronic implants or metal implants
- •Pregnancy or breast-feeding
- •In the process of quitting smoking
研究组 & 干预措施
Real transcranial Direct Current Stimulation
This group will receive bilateral tDCS (left cathodal/right anodal) over the DLPFC. The stimulation will take place two times daily for 13 minutes with a rest interval of 20 minutes for three days in one week.
干预措施: tDCS (Device)
Sham tDCS
The control group receives sham, for which the stimulator will be gradually turned off after 30 seconds.
干预措施: tDCS (Device)
结局指标
主要结局
Mean number of cigarettes a day at 3 months follow up
时间窗: 3 months
The mean number of cigarettes will be measured at three months follow-up by means of Ecological Momentary Assessments (EMA). This means that participants are asked to report every cigarette they smoke at the moment they're about to smoke it with an app on their mobile phone. Participants do this during the week before the last EEG session at three months follow-up.The mean number will be calculated over this week
次要结局
- Feedback Related Negativity (FRN): Event Related potential (ERP) of reward processing(3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up)
- Course of cigarette consumption(2 weeks)
- Mean number of cigarettes a day one week after tDCS(1 week)
- Craving at 3 months follow-up(3 months)
- Craving one week after tDCS(1 week)
- Behavioral responses of risk-taking(3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up)
- Reward related P300: Event related potential (ERP) of reward processing(3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up)
- P300: Event related potential (ERP) of inhibitory control(3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up)
- Affect one week after tDCS(1 week)
- Behavioral responses of inhibitory control(3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up)
- N200: Event related potential (ERP) of inhibitory control(3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up)
- Affect 3 months after tDCS(3 months)
- Error related negativity: Event related potential (ERP) of error processing(3 times: at baseline, one day after all tDCS sessions, and at 3 months follow-up)
研究者
Ingmar Franken
Prof. Dr.
Erasmus Medical Center