Optimizing Electrical Stimulation for Clinical Applications (the OptES Study): Severe Psychological Stress - a Pilot Study (OptES-Stress-pilot)
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 主要终点
- Impact of Event Scale (Change in scores of event-related anxiety)
研究概览
简要总结
The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label pilot study in patients who have faced severely stressful life events.
详细描述
Transcranial direct current stimulation (tDCS) is a novel neuromodulation method that has been observed to be promising in treatment of psychiatric disorders such as depression. Nevertheless, knowledge related to the treatment of psychological stress and its main symptom, anxiety, is very scarce. The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of acute anxiety in an open-label pilot study in patients who have faced severely stressful life events.
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
- None
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
- 否
入选标准
- •Age 18-65 years
- •Naïve to tDCS
- •Right-handed
- •Impact of Event Scale Scores ≥ 30
排除标准
- •Metal implants inside skull or eye
- •Severe skin lesions at the electrode placement area
- •History of epilepsy or previous seizures
- •Pregnant or breast-feeding
- •Pacemaker
- •History of intracerebral bleeding during the past six months
- •Major psychiatric conditions according to the Structured Clinical Interview for DSM-IV Disorders, i.e., Lifetime diagnoses of bipolar mood disorder or psychotic disorder
- •DSM-IV diagnosis for one or more of the following conditions during the past six months: unipolar mood disorder, anxiety disorders, eating disorders, or substance dependence/abuse.
- •Use of psychotropic medication (i.e., antipsychotic and antidepressant medications, mood stabilizers, psychostimulants, hypnotics and tranquilizers) during the past six months
研究组 & 干预措施
Treatment 1
NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
干预措施: NeuroConn DC Stimulator Plus tDCS (Device)
Treatment 2
NeuroConn DC Stimulator Plus tDCS treatment protocol no 1
干预措施: NeuroConn DC Stimulator Plus tDCS (Device)
结局指标
主要结局
Impact of Event Scale (Change in scores of event-related anxiety)
时间窗: 12 days
Change in scores of event-related anxiety
次要结局
未报告次要终点
研究者
Soili Lehto
Adjunct professor
University of Eastern Finland