Modulating Decision-Making and Impulse Control With Transcranial Direct Current Stimulation (tDCS) Over the Orbitofrontal Cortex (OFC): A Randomized and Sham-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in the net score of the Iowa Gambling Task
研究概览
简要总结
In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy participants.
详细描述
In this single-blind, three-arm and sham-controlled study, we will assess whether transcranial direct current stimulation (tDCS; a safe and non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate decision-making and impulse control in healthy volunteers. We hypothesize that tDCS applied to the OFC, in comparison to sham tDCS, will significantly enhance decision-making and impulse control. For this study we will enroll 45 healthy individuals aged 18-60 years. These individuals will be assessed with a battery of computerized tasks as well as clinician-administered and self-reported questionnaires on depression and anxiety. Assessments will be carried out before and after a single 30-minute tDCS session.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women aged 18 to 60 years
排除标准
- •Presence any psychiatric and/or neurological illness
- •Psychoactive substance abuse/dependence in the past 6 months
- •Current use of medication(s) that might influence cognition and/or affective status
- •Presence of an uncontrolled medical disease (e.g., cardiovascular, renal)
- •Pregnancy and/or lactation
- •Specific contraindication for tDCS (e.g., metallic head implant).
研究组 & 干预措施
Left OFC Group
Anode applied to the left OFC and cathode applied to the right OFC
干预措施: Transcranial Direct Current Stimulation (Device)
Right OFC Group
Anode applied to the right OFC and cathode applied to the left OFC
干预措施: Transcranial Direct Current Stimulation (Device)
Sham tDCS
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Change in the net score of the Iowa Gambling Task
时间窗: Before and after a 30-minute tDCS session
次要结局
- Change in the number of risky choices in the Game of Dice Task(Before and after a 30-minute tDCS session)
- Change in the interference index in the Stroop Color-Word Test(Before and after a 30-minute tDCS session)
- Change in the "average-adjusted number of pumps" in the Balloon Analog Risk Task(Before and after a 30-minute tDCS session)
- Change in the number of commission errors in the Continuous Performance Task(Before and after a 30-minute tDCS session)
- Change in the stop-signal reaction time in the Stop-Signal Task(Before and after a 30-minute tDCS session)
研究者
MARCELO T. BERLIM
Director, Neuromodulation Research Clinic
Douglas Mental Health University Institute