Treatment of Depersonalization Disorder With Transcranial Magnetic Stimulation (TMS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cambridge Depersonalization Scale (CDS)
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of transcranial magnetic stimulation in the treatment of Depersonalization Disorder (DPD).
详细描述
This study is a research trial of an outpatient, non-medication, non-invasive investigational treatment called Transcranial Magnetic Stimulation (TMS). TMS applies a magnetic field to the brain for a brief period of time. TMS is a procedure that involves 30 minute-long daily sessions every weekday for a series of weeks. The investigators are testing whether TMS can treat Depersonalization Disorder (DPD).
This is an open-label study. All patients will receive active treatment. DPD symptoms will be monitored through weekly self-report questionnaires as well clinical ratings with a doctor.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients, 18 to 70 years of age.
- •Primary diagnosis of Depersonalization Disorder.
- •Duration of the index episode of at least a year.
- •Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and be to continue at the same dose(s) through the duration of the study.
- •Capable and willing to provide informed consent
排除标准
- •Individuals with a neurological disorder including, but not limited to: brain lesion; history of seizures; history of cerebrovascular accident; history of stroke; cerebral aneurysm, Dementia; Parkinson's Disease; Huntington's chorea; Multiple Sclerosis.
- •Increased risk of seizure for any reason, including prior head trauma with loss of consciousness for 5 minutes or more.
- •Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- •Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
- •If participating in psychotherapy, must have been in stable treatment for at least three months prior to entry into the study, with no anticipation of change in frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial.
- •Known or suspected pregnancy.
- •Women who are breast-feeding
结局指标
主要结局
Cambridge Depersonalization Scale (CDS)
时间窗: 6, 9, or 12 weeks
Change on CDS from baseline. Scale item number: 29 Item score range: Frequency: 0 - 4, Duration: 0-5 Minimum CDS score: 0 Maximum CDS score: 261 Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.
次要结局
- Clinical Improvement (CGI-S)(6, 9, or 12 weeks)