The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
研究概览
简要总结
The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an effect on symptoms of PTSD compared to sham rTMS treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary diagnosis of PTSD as determined by a structured interview using the Mini International Neuropsychiatric Interview (MINI)
- •no change in psychotropic medications within 4 weeks before the start of rTMS
- •age > 19 years and < 70 years
- •competency to give informed consent
排除标准
- •any non-fixed metal object or implant (including cochlear implants) in brain, skull, scalp, or neck within 30 cm of the magnetic rTMS coil
- •implantable devices, including cardiac pacemakers and defibrillators
- •other contraindications to rTMS, including history of seizures (except childhood febrile seizures) or recent and unexplained syncope, first-degree relative with a history of epilepsy, treatment with a medication known to substantially decrease the seizure threshold, or pregnancy
- •psychiatric diagnoses of psychosis or psychotic disorder (including psychotic depression), bipolar type I disorder, or organic mental disorders
- •substance abuse/dependence within the past 3 months
- •active suicidal risk as judged by the clinician
- •borderline or antisocial personality disorder
- •acute medical illness, including cancer
- •any significant central nervous system disorder, such as brain mass, stroke, etc.
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
时间窗: Endpoint (treatment end) (Week 2).
The Clinician-Administered PTSD Scale-IV (CAPS-IV) is a semi-structured instrument that assesses the intensity, frequency, and severity of PTSD symptoms. It consists of 17 symptom items, each rated on a 0-4 scale for frequency and a 0-4 scale for intensity, with higher scores indicating greater frequency/intensity. The frequency and intensity scores are then summed to yield a total item severity score (range 0-8). The minimum score of the overall scale is 0 and maximum is 17 items \* maximum severity score of 8 = 136 (higher scores indicating more severe symptoms).
次要结局
- PTSD Checklist for Civilians (PCL-C)(Endpoint (Week 2).)
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)(Endpoint (Week 2))
- Hamilton Depression Rating Scale, 21-item Version (HDRS-21)(Endpoint (Week 2))
- Beck Anxiety Inventory (BAI)(Endpoint (Week 2))
- Generalized Anxiety Disorder (GAD-7) Scale(Endpoint (Week 2))
研究者
Peter Y Chan
Principal Investigator
University of British Columbia