Optimizing Transcranial Electrical Stimulation for Clinical Applications (the OptES Study): A Pilot Study to Determine a Candidate Protocol for Treatment of Anxiety (OptES-Anx)
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Beck Anxiety Inventory
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 anxiety in an open-label pilot study.
详细描述
The investigators examine the efficacy of two different transcranial direct current stimulation (tDCS) stimulation protocols in the treatment of anxiety in an open-label pilot study in patients with chronic pain. The investigators also seek to detect autonomic nervous system changes induced by the tDCS, and develop new methods for the measurement of autonomic nervous system functions.
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
- •Beck Anxiety Scores >= 26
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
- •Lifetime DSM-IV diagnosis of bipolar mood disorder or psychotic disorder
- •DSM-IV diagnosis for substance abuse or dependence 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 2
干预措施: NeuroConn DC Stimulator Plus, tDCS (Device)
结局指标
主要结局
Beck Anxiety Inventory
时间窗: 12 days
change in scores of anxiety
次要结局
未报告次要终点
研究者
Soili Lehto
Adjunct professor
University of Eastern Finland