Low-Frequency Versus High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 主要终点
- Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
研究概览
简要总结
This is a randomized placebo/sham controlled, double-blind study investigating the efficacy of high- and low-frequency rTMS applied to the right DLPFC at either 1 Hz, 10 Hz, or sham rTMS as compared to an OASIS treatment as usual group for the treatment of PTSD symptoms.
详细描述
The study will be carried out within the Overcoming Adversity and Stress Injury Support (OASIS) program administered by Naval Medical Center San Diego (NMSD). OASIS is a residential treatment program developed for active duty service members diagnosed with combat related PTSD. OASIS is a 9 week program in which cohorts of 10 patients undergo a variety of therapeutic activities with a focus on cognitive processing therapy (CPT) of combat trauma conducted in both group and individual formats.
Subjects who qualify will be assigned by block randomization to one of four arms:
- 1 Hz rTMS of the right dorsolateral prefrontal cortex
- 10 Hz rTMS of the right dorsolateral prefrontal cortex
- Sham rTMS of the right dorsolateral prefrontal cortex
- OASIS treatment as usual
Treatment will be administered in 10 daily sessions, conducted on weekdays, for 2 consecutive weeks. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 否
入选标准
- •Participant in the OASIS program
- •Willing and able to give informed consent
- •Diagnosis of Post-Traumatic Stress Disorder as determined by the CAPS CAPS score of at least 50
- •Males or females between 18-65 years of age
排除标准
- •Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Active Substance use
- •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 30 days Patients with neurological disorder leading to increased intracranial pressure
- •Participation in other interventional treatment protocols (participants of monitoring/observational studies can be included)
研究组 & 干预措施
Active Comparator:1 Hz rTMS
Active Comparator: 1 Hz rTMS
干预措施: Active Comparator: 1 Hz rTMS (Other)
Active Comparator:10 Hz rTMS
Active Comparator:10 Hz rTMS
干预措施: Active Comparator: 10 Hz rTMS (Other)
Sham Comparator:Sham rTMS
Sham Comparator: Sham rTMS
干预措施: Sham Comparator: (Other)
OASIS treatment as usual
OASIS treatment as usual
结局指标
主要结局
Change in Clinician Administered PSTD Scale (CAPS) score from Baseline to week 4
时间窗: Baseline and Week 4
Clinician Administered PSTD Scale (CAPS)
次要结局
未报告次要终点
研究者
Donald Hurst
LCDR Donald Hurst, MD, MC USN
United States Naval Medical Center, San Diego