Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 4
- 主要终点
- Cambridge Depersonalization Scale (CDS)
研究概览
简要总结
The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.
详细描述
Depersonalization disorder is characterised by a profound disruption of self-awareness. Depersonalization symptoms may occasionally arise (30 to 70% of the population) or may become chronic in depersonalization disorder. Its prevalence is around 2.4% in the general population. This disorder is particularly resistant to pharmacological treatments. This study is a randomized, double-blind, placebo-controlled study, and the investigators are testing the therapeutic efficacy of neuronavigated repetitive Transcranial Magnetic Stimulation (TMS) of right angular gyrus in patients with depersonalization disorder.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatients aged over 18 years old
- •Suffering from depersonalization disorder according to DSM IV-TR
- •Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and must be continued at the same dose(s) through the duration of the study.
- •Patient provided informed written consent
- •Patient covered by a contributory social security scheme
- •Aged over 18 years old
- •Absence of a personal history of psychiatric disorders
- •Provided informed written consent
- •Covered by a contributory social security scheme
排除标准
- •Patients:
- •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.
- •history of neurosurgery,
- •neurosurgical ventriculoperitoneal bypass valves
- •personal and / or family history of seizures or epilepsy
- •Dental device
- •Pregnant woman
- •Claustrophobic subjects
- •Not cooperating or agitated patients
- •Medications that reduce the seizure threshold, such as clozapine, bupropion, methadone and / or theophylline
- •Alcohol abuse and / or toxic substances in the last 12 months
- •Substance dependence except tobacco
- •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.
- •neurosurgical ventriculoperitoneal bypass valves
- •Claustrophobic subjects
- •Pregnant woman
- •Not cooperating or agitated patients
- •Dental device
结局指标
主要结局
Cambridge Depersonalization Scale (CDS)
时间窗: At 3 months after the treatment
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder. The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale
次要结局
- Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS(At 3 months)
- Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity(Visit 3 : end of the TMS sessions (between 19 and 25 days after V2 - start of TMS))