A Pilot Study Investigating Transcranial Direct Current Stimulation (tDCS) to Enhance Mindfulness Meditation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 主要终点
- Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit One
研究概览
简要总结
The purpose of this study is to determine if a new technology applied while listening to a mindfulness meditation tape can affect one's ability to achieve a state of "mindfulness." The new technology is called transcranial direct current stimulation, or tDCS.
详细描述
Many people initially attempt meditation but cannot get their mind to be still. Or they do not get quick results and find it frustrating. Thus, the number of people benefiting from meditation would increase if there were a method of making it easier to perform. Moreover, establishing the actual brain mechanisms involved in the benefits of meditation would potentially open up synergistic treatments and approaches.
The investigators will investigate the use of a new, non-invasive brain stimulation method called transcranial direct current stimulation (tDCS) to augment a state of mindfulness. tDCS is a safe, inexpensive, non-invasive brain stimulation modality that has the capability of focally increasing or decreasing cortical activity. Anodal stimulation produces positive DC stimulation and is associated with increased cortical activity, whereas Cathodal stimulation produces a negative DC stimulation and is associated with decreased cortical activity. Cortical activity changes occur both during and after stimulation in a dose response fashion (higher current density and longer duration of stimulation produces larger and longer lasting effects).
The investigators will be investigating the use of tDCS to augment mindfulness meditation in a double-blind, crossover, randomized, sham-controlled trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy control volunteers.
- •meditation naive
排除标准
- •Pregnancy,
- •History of Mental illness or neurological disorders,
- •prior meditative experiences
研究组 & 干预措施
Meditation and Active Stimulation 1
Electrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.Participant will then receive 20 minutes of tDCS with Anode over F8 and cathode over left supraorbital area with 1 milliamp(mA) stimulation with intervention administration delivered by tDCS via Chattanooga Ionto Iontophoresis System-Phoresor.
干预措施: tDCS via Chattanooga Ionto Iontophoresis System-Phoresor (Device)
Meditation and Active Stimulation 2
Electrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.Participant will then receive 20 minutes of tDCS with Anode over F8 and cathode over left supraorbital area with 2 mA stimulation with intervention administration delivered by tDCS via Chattanooga Ionto Iontophoresis System-Phoresor.
干预措施: tDCS via Chattanooga Ionto Iontophoresis System-Phoresor (Device)
Meditation and Sham Stimulation
Electrodes will then be placed on the participant and participant will then listen to a meditative recording instructing to focus on participant's breath that will last approximately 5 minutes.The participants in the sham study will receive Sham tDCS (no stimulation) with Anode over F8 and cathode over left supraorbital area with intervention administration delivered by Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor
干预措施: Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor (Device)
结局指标
主要结局
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit One
时间窗: Baseline (Visit 1/Week 1) Post Stimulation (Visit 1/Week 1). Through Visit 1 completion, an average of 25 minutes
During Experimental Visit 1 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post stimulation.
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit Two
时间窗: Baseline (Visit 2/Week 2) Post Stimulation (Visit 2/Week 2). Through Visit 2 completion, an average of 25 minutes
During Experimental Visit 2 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post stimulation.
Change from Baseline Mood Visual Analog Scale (Mood VAS) at Post Stimulation of Experimental Visit Three
时间窗: Baseline (Visit 3/Week 3) Post Stimulation (Visit 3/Week 3). Through Visit 3 completion, an average of 25 minutes
During Experimental Visit 3 the participant will complete the Mood Visual Analog Scale before listening to a meditative tape recording and receiving either active tDCS or sham tDCS for 20 minutes. The participant will then fill out the Mood Visual Analog Scale post stimulation.
次要结局
未报告次要终点