Modulating Default Mode Network Function: A Transcranial Direct Current Stimulation (TDCS) Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning.
研究概览
简要总结
The primary purpose of this research is to gather scientific information about how different people's brains work when they look at different types of pictures. This will help to improve the investigators' understanding of the way the brain works for people who are depressed or anxious, and this knowledge could help lead to better diagnosis and treatment.
详细描述
In this study the investigators are examining the effects of weak electrical stimulation on brain activity as measured by functional magnetic resonance imaging (fMRI). MRI is a widely used method to obtain high resolution brain pictures that are routinely used for diagnostic and clinical purposes. The electrical stimulation is applied on the scalp with a non-FDA approved method called tDCS (transcranial Direct Current Stimulation), typically equivalent to what a 6V battery would produce (and up to no more than 15V). To compare, an AA battery delivers current at 1.5 volt. While almost unnoticeable to the participants, these currents can still temporarily affect brain activity without causing adverse effects. This stimulation would be applied while the participants are in the MRI scanner so that the brain activity can be measured. The participants will have the opportunity to have a test session with the stimulation outside the scanner to get familiar with it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18-30years old
- •Score > 10 on the QIDS or > 60 on the PROMIS-A
- •We will use a flexible extreme groups recruitment strategy to ensure an adequate distribution of ESC scores. We will ensure that at least 62% of the sample will be composed of those scoring .5 SD above or below the mean, as measured by the NEO-PI-R. This value corresponds to the expected values assuming a normal distribution of the trait.
- •Normal or corrected to normal vision with contact lenses
- •Able to provide informed consent in English
- •Right-handed (Annett criteria)
排除标准
- •Have a history of head trauma with loss of consciousness.
- •Have a systemic medical illness that may impact fMRI measures of cerebral blood flow.
- •Meet standard exclusion criteria for fMRI scanning (e.g. claustrophobia, cardiac pacemakers, neural pacemakers, surgically implanted metal devices, cochlear implants, metal braces, or other MRI non-safe metal objects in the body).
- •Are pregnant (self report and tested for as part of any scan by the scanning center and not this protocol)
- •Not native English speaking or not fluent
- •Premorbid NAART IQ estimate<85;
- •Visual disturbance (worse than 20/40 Snellen visual acuity) that is not corrected
- •If have visual disturbance, only access to correction with glasses (i.e., no access to contact lenses).
- •Left/mixed handedness (Annett criteria), to ensure a uniform hemispheric dominance for interpretation of neuroimaging data
- •Active suicidal ideation in need of immediate treatment
- •Scoring below the cutoffs on both the QIDS and the PROMIS-A
- •History of alcohol/substance use disorder (including nicotine) and/or illicit substance use (except cannabis) over the last 3 months, determined by the MINI. Lifetime/present cannabis use (non-disordered levels) will be allowed, given its common usage in individuals in this age range.
- •Current or past psychotic-spectrum disorder
- •History of seizures
结局指标
主要结局
Blood Oxygen Level Dependent (BOLD) Response in the Precuneus During an Emotion Regulation Task Completed During fMRI Scanning.
时间窗: 1 week (between baseline and repeat scanning)
The investigators will determine the effects of TDCS on BOLD response in the precuneus/posterior cingulate gyrus. The BOLD signal is a measure of regional blood flow in the brain and is used as a proxy for neural activity in specific brain regions. Values below represent pre-post change in BOLD response to the emotion regulation task that participants complete during fMRI scanning. We hypothesize that tDCS applied to the target used in this study will decrease BOLD signal (lower values) during critical components of this task, normalizing function in this region.
次要结局
- The Percentage of Patients Who Reported a Side Effect in the Active tDCS Condition But Not the Sham tDCS Condition(30 minutes to 1 hour (the period during which the tDCS device was worn) on each of two scan days)
研究者
Jay Fournier
Assistant Professor of Psychiatry
University of Pittsburgh