The Effects of Preconditioning Theta Burst Stimulation With Transcranial Direct Current Stimulation on Stress Regulation in Healthy Controls: a Double-blind Sham-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Changes in heart rate variability (HRV)
研究概览
简要总结
The study examines the effects of the combined use of two different non-invasive brain stimulation (NIBS) techniques targeting the DLPFC on stress reactivity and recovery.
详细描述
Transcranial Direct Current Stimulation (tDCS) will be combined with intermittent Theta Burst Stimulation (iTBS) in order to maximize the effects coming from each of the techniques on their own. A group of 74 healthy participants wil be submitted to two different stimulation protocols (sham tDCS + active iTBS and active tDCS + active iTBS) with one-week in between and results on stress reactivity will be examined. In order to improve therapeutic protocols, this study with healthy participants is a crucial first step in order to further conduct clinical studies with psychiatric samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, 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
- •Aged between 18-45 years old
排除标准
- •The presence of psychiatric disorders
- •Usage of psychotropic medication
- •Any or cardiovascular neurological condition
- •Personal or family history of epilepsy or other neurological disorders
- •Unstable medical condition, as well as chronic pain conditions, (such as fibromyalgia) or increased blood pressure
- •Eye disease(s)
- •Current substance abuse
- •Inner ear prosthesis
- •Any implanted electronic device susceptible for magnetic field radiation (e.g. pacemaker)
- •Any implanted metal device in the head region
- •Metal objects or magnetic objects in the brain or around the head (only removable earrings & piercing are allowed)
- •Recent neurosurgical interventions
- •Pregnancy
- •Skin problems in the head region
- •Recent fractures or wounds on the hand
结局指标
主要结局
Changes in heart rate variability (HRV)
时间窗: Through study completion, an average of two weeks
Variability in time between two heartbeats
次要结局
- Changes in heart rate (HR)(Through study completion, an average of two weeks)
- Changes in blood pressure (BP)(Through study completion, an average of two weeks)
- Changes in anxiety features - self-report(Through study completion, an average of two weeks)
- Changes in state-dependent ruminative thinking(Through study completion, an average of two weeks)
- Changes in electrodermal activity (EDA)(Through study completion, an average of two weeks)
- Changes in state-dependent mood(Through study completion, an average of two weeks)