Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Performance on emotional working memory task
研究概览
简要总结
Testing a Causal Model of Cognitive Control Deficits in Posttraumatic Stress Disorder (PTSD)
详细描述
The purpose of the present study is to examine the effects of transcranial magnetic stimulation (TMS) on cognitive control among individuals with posttraumatic stress disorder (PTSD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Over 18 years of age
- •Endorse lifetime exposure to at least one Criterion A traumatic event
- •Report clinically significant posttraumatic stress disorder (PTSD) symptoms (score of ≥ 33 on the PTSD Checklist for DSM-5 [PCL-5]).
排除标准
- •Endorse medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.)
- •Report an unstable medical condition or any current medical condition that precludes safe participation in the trial (e.g., unstable metabolic abnormality, unstable angina, etc.)
- •Report any history or diagnosis of dementia or other cognitive disorder, which may interfere with engagement
- •Report any history or diagnosis of Severe Traumatic Brain Injury
- •Report any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness, which precludes safe participation in the trial
- •Report a primary obsessive-compulsive disorder (OCD) diagnosis
- •Report an active substance use disorder (within last 3 months) or any current substance use that precludes safe participation in the trial
- •Report suicide risk that precludes safe participation in the trial, defined as clinical impression that the participant is at significant risk for suicide (i.e., greater than moderate level of suicide risk, in accordance with the Joiner et al. (1999) suicide risk framework)
- •Report an inability to stop taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
- •Report a current, planned, or suspected pregnancy
研究组 & 干预措施
Intermittent theta burst stimulation to right dorsolateral prefrontal cortex
Participants will receive intermittent theta burst stimulation (iTBS) to the experimental target area, the right dorsolateral prefrontal cortex (rDLPFC)
干预措施: Transcranial Magnetic Stimulation (TMS) (Procedure)
Intermittent theta burst stimulation to vertex of the skull
Participants will receive intermittent theta burst stimulation (iTBS) to the active comparator area, the vertex of the skull
干预措施: Transcranial Magnetic Stimulation (TMS) (Procedure)
结局指标
主要结局
Performance on emotional working memory task
时间窗: 5 hours
Accuracy and reaction time on a task measuring working memory in the presence of trauma-related distractor images
次要结局
未报告次要终点
研究者
Carter Bedford
Principal Investigator
Florida State University