Neuronavigated Theta Burst Stimulation in Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- HAMD
研究概览
简要总结
In this randomized controlled trial we will treat 80 patients with depression with intermittent theta burst stimulation in two parallel arms. Both arms are active interventions differing with respect to positioning of the treatment coil - one arm with neuronavigation and one arm with targeting according to EEG Position representing the left dorsolateral prefrontal cortex. Randomisation will be balanced for in- and out-patients and for the treatment arms.
详细描述
Intermittent Theta burst Stimulation (iTBS) is a specific type of repetitive transcranial magnetic Stimulation (rTMS). rTMS of the left prefrontal cortex was shown to be effective in the treatment of Depression. Recent studies showed that iTBS probably is as effective as rTMS.
One possibility to increase to efficacy of rTMS/iTBS is to use neuronavigation. With neuronavigation the coil Position can be targeted with an accuracy in the range of millimeters. Furthermore the Stimulation Position can be ensured during one single session and over the course of the daily Treatments.
The aim of the present study is to investigate the benefit of neuronavigation in the Treatment of Depression with iTBS by using two arms one with targeting the Stimulation site with neuronavigation and one by using the EEG Position F3 as target by using head caps for marking the position.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •unipolar or bipoloar depressive Episode according to ICD-10
- •at least moderate Depression according to Hamilton Depression Rating Scale or ICD-10
- •if applicable stable medication with psychoactive compounds for out-patients
- •if applicable no or stable Treatment for Depression during the course of the Trial
- •residence in Germany and mother tongue German
- •written informed consent
排除标准
- •Meeting the contraindications for transcranial magnetic Stimulation or magnetic resonance Imaging (electic devices or metal implants in the Body, e.g. cardiac pace maker, Insulin ppump)
- •neurological disorders (e.g. cerebrovascular Events, neurodegenerative disorder, epilepsy, brain malformation, severe head Trauma)
- •addictive disorder with consumption in the last two years
- •regular intake of benzodiazepines
- •participation in another study parallel to the Trial
- •pregnancy or breastfeading period
- •psychiatric confinement
结局指标
主要结局
HAMD
时间窗: 4 weeks
Hamilton Depression Rating Scale
次要结局
- HAMD(16 weeks)
- PHQ-9(16 weeks)
- MDI(16 weeks)
- WHOQOL-BREF(16 weeks)
- CGI(16 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Head of Center II and out-patient clinic of the Department of Psychiatry and Psychotherapy
University of Regensburg