Prefrontal Transcranial Random Noise Stimulation in Patients With Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))
研究概览
简要总结
Transcranial random noise stimulation is used to stimulate the prefrontal cortices in patients with depression. It's a placebo-controlled two-arm study.
详细描述
Transcranial random noise stimulation (tRNS) is a non-invasive electric stimulation technique of the brain which was shown to be superior effective in contrast to other electric stimulation such as transcranial direct current stimulation (tDCS). These studies investigated mainly healthy controls and specific tasks. Only one case report is available for depression. Here we stimulate patients with depression with tRNS in a placebo-controlled two-arm design. Stimulation will be done as add-on to standard therapy. Electrodes will be applied over both dorsolateral prefrontal cortices which are standard target points of tDCS and also transcranial magnetic stimulation in depression.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •episode of depression (unipolar or bipolar) ( ICD-10)
- •female or male between 18 and 70 years old
- •skills to participate in all study procedures
- •18 or more points in the Hamilton rating scale or depression
- •written informed consent
排除标准
- •clinically relevant unstable internal or neurological comorbidity
- •evidence of significant brain malformations or neoplasm, head injury
- •cerebral vascular events
- •neurodegenerative disorders affecting the brain or prior brain surgery
- •metal objects in and around body that can not be removed
- •pregnancy
- •alcohol or drug abuse
- •eczema on the head
- •heart pacemaker
- •high dose tranquillizers
研究组 & 干预措施
Verum Prefrontal tRNS
2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.
干预措施: Verum Prefrontal tRNS (Device)
Placebo Prefrontal tRNS
2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.
干预措施: Placebo Prefrontal tRNS (Device)
结局指标
主要结局
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))
时间窗: day 3; day 19
Change in depression severity measured by the 21-item Hamilton Depression Rating Scale (baseline (-day 3) versus end of treatment (day 19))
次要结局
- Change in the Beck Depression Inventory over the course of the trial(day 3; day 5; day 12; day 19; day 75)
- Change in alertness, working memory and divided attention over the course of the trial(day 3; day 19; day 75)
- Change in depression severity measured by the Major Depression Inventory over the course of the trial(day 10; -day 3; day 5; day 12; day 19; day 75)
- Number of responders (response = decrease of the Hamilton Depression rating scale for at least 50%) (baseline versus end of treatment)(day 3; day 19)
- Change in the Clinical Global Impression Scale over the course of the trial(day 3; day 5; day 12; day 19; day 75)
研究者
Berthold Langguth, MD, Ph.D.
MD, PhD
University of Regensburg