Trigeminal Nerve Stimulation for PTSD and Depression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Hamilton Depression Rating Scale-17 Item
研究概览
简要总结
This is a 20-subject, dose finding study to examine the use of external trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications. Our primary objective is the examination of TNS in this patient population.
To accomplish our specific aims, the investigators will test the following specific hypotheses:
- Subjects will show improvement in ratings of mood, PTSD, and other symptoms during the eight-week period.
- Subjects will show improvement in ratings of life functional capacity and quality of life with TNS.
- Subjects will report the TNS treatments to be acceptable in terms of side effects and burden of using the device.
详细描述
A total of 20 subjects with Major Depressive Disorder (MDD) co-occurring with Post Traumatic Stress Disorder (PTSD), ages 18 to 75 years, will be consented and join this project at UCLA.
The project will use TNS in under open-label conditions, using the same stimulation parameters as have been used in prior studies in MDD by itself and in treatment-refractory epilepsy. Subjects will be seen every two weeks during the 8 week study. At the end of the 8 weeks, the TNS systems will be returned and the adjunctive treatment will end. The co-primary endpoints are the changes in depression severity and in PTSD severity from enrollment to the week 8 visit.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Hamilton Depression Rating Scale-17 Item
时间窗: Baseline, week 8
Change in PTSD Checklist score
时间窗: Baseline, Week 8
次要结局
- Change in life functional capacity and quality of life scales(baseline, week 8)
- Changes in vital signs recordings(At every visit for 8 weeks)
- Changes in Safety Assessment Measures(At every visit for 8 weeks)
研究者
Ian A. Cook, M.D.
Principal Investigator
University of California, Los Angeles