Orbitofrontal Cortex Transcranial Magnetic Stimulation in Patients With Emotionally Unstable Personality Disorder and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Hamilton depression rating scale (HDRS)
研究概览
简要总结
Treatment of depression with conventional transcranial magnetic stimulation (rTMS) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (DLPFC) stimulation. Recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional DLPFC rTMS. Orbitofrontal cortex (OFC) seem to be involved in the etiopathology of emotionally instable personality disorders. Thus, the present one-arm trial is a pilot study investigating if OFC rTMS is feasable, tolerable and effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •ICD-10: F60.30 or F60.31
- •depressive symptoms and HAMD-21 score of at least 7
- •sex: female and male
- •residence in Germany and German speaking
- •written informed consent
排除标准
- •meeting the contraindications for transcranial magnetic stimulation (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump)
- •neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma)
- •participation in another study parallel to the Trial
- •other mental or somatic illness which is not compatible with participation according to the principal investigator
- •pregnancy or breastfeeding period
- •psychiatric confinement
结局指标
主要结局
Hamilton depression rating scale (HDRS)
时间窗: 4 weeks
measurment of depressivity: 21 items with a range 0-65 and higher values indicating higher scores
次要结局
- Depression module of the Patient health questionnaire (PHQ-D)(4 weeks, 12 weeks)
- nicotine use(2 weeks, 4 weeks, 12 weeks)
- Major Depression Inventory (MDI)(2 weeks, 4 weeks, 12 weeks)
- Hamilton depression rating scale (HDRS)(2 weeks, 4 weeks, 12 weeks)
- Borderline Symptom List (BSL-23)(2 weeks, 4 weeks, 12 weeks)
- Clinical global impression (CGI)(2 weeks, 4 weeks, 12 weeks)
- Barratt impulsiveness Scale (BIS)(4 weeks, 12 weeks)
- Numeric rating scale of pain(2 weeks, 4 weeks)
研究者
Berthold Langguth, MD, Ph.D.
Clinical Professor
University of Regensburg