High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Post Traumatic Stress Disorder
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale , CAPS
研究概览
简要总结
The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)
详细描述
This is a randomized single-blind pilot study investigating the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex at either 10 Hz or 20 Hz as compared to a treatment as usual group for the treatment of Post Traumatic Stress Disorder (PTSD) symptoms.
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 (Outcomes Assessor)
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
- 是
入选标准
- •Willing and able to give informed consent
- •Diagnosis of Post-Traumatic Stress Disorder as determined by the SCID
- •CAPS score of at least 40
- •Males or females between 18-65 years of age
- •Willing to give up new psychotherapy or changes in psychiatric medications during the course of the TMS treatment.
排除标准
- •Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder
- •Patients with HDRS score ≥ 18
- •A metallic implant in cranium (except the mouth)
- •Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety
- •ECT treatment within the last three months
- •Patients with a history of epilepsy
- •Patients with neurological disorder leading to increased intracranial pressure
- •Participation in a new course of psychotherapy during the 24 days of the study
- •A new psychiatric medication within 6 weeks of enrolling in the study
- •Changes in psychiatric medication within 2 weeks of starting the study
研究组 & 干预措施
Treatment as usual
Treatment as usual, wait list control group
rTMS at 10Hz
10 Hz rTMS of the right dorsolateral prefrontal cortex
干预措施: 10 Hz rTMS of the right dorsolateral prefrontal cortex (Other)
rTMS at 20Hz
20 Hz rTMS of the right dorsolateral prefrontal cortex
干预措施: 20 Hz rTMS of the right dorsolateral prefrontal cortex (Other)
结局指标
主要结局
Clinician Administered PTSD Scale , CAPS
时间窗: day 10
The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD.
次要结局
- Posttraumatic Stress Disorder Checklist, PCL(week 24)