Potentiation of Trauma Exposure in Post-traumatic Stress Disorder by Repeated Transcranial Magnetic Stimulation : A Control Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 主要终点
- Change from baseline Score at Clinician administered PTSD scale
研究概览
简要总结
The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary reactivation of personal traumatic memories with neuromodulation of the right dorsolateral prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.
详细描述
Post-Traumatic Stress Disorder (PTSD) is characterized by intrusive and persistent memory of past result from an event causing or able to cause death, be a threat of death, a severe injury or constitute a threat for physical integrity. It is a frequent disorder in general population (8%). In France, The most frequent traumatic events causing PTSD are serious accidents, rape, physical assaults, violence, etc. PTSD treatment involves antidepressant and cognitive and behavioural psychotherapy, which encourage exposure to elements that remind the trauma (memories, circumstances), with the objective of reducing the fear associated with the traumatic memories. Innovative therapeutic strategies aim to improve the psychotherapeutic effect with enhancement drugs or using neuromodulatory techniques, such as repeated transcranial magnetic stimulation (rTMS).
The aim of this study is to assess the efficacy in PTSD treatment of concomitant voluntary reactivation of personal traumatic memories with neuromodulation of the right dorsolateral prefrontal cortex using 10Hz rTMS, compared to 1Hz rTMS, during 2 weeks.
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, Investigator)
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
- •PCLS score >40
- •Able to give his written informed consent
- •Not participating another study
- •Affiliation to a social security system
- •Having a PTSD for 3 months
- •No treatment modification for 4 weeks (Psychotropic treatment or structured psychotherapy)
排除标准
- •Partially deaf with equipment
- •people with identified neurological disease
- •people with addiction to psychoactive substance
- •people who can't conform to tests
- •people having a contraindication for rTMS (cochlear implant )
- •people suffering from chronicle or acute delusional disorder
- •any circumstances making the people unable to understood nature, aim or consequences of the study.
研究组 & 干预措施
rTMS 1Hz
Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 1Hz on dorsolateral prefrontal cortex (1Hz rTMS is describe in the literature to have no effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter . Heart rate measure With electrocardiogram
干预措施: conductivity meter (Device)
rTMS 1Hz
Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 1Hz on dorsolateral prefrontal cortex (1Hz rTMS is describe in the literature to have no effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter . Heart rate measure With electrocardiogram
干预措施: rTMS 1Hz (Device)
rTMS 1Hz
Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 1Hz on dorsolateral prefrontal cortex (1Hz rTMS is describe in the literature to have no effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter . Heart rate measure With electrocardiogram
干预措施: psychoneurological assessment (Behavioral)
rTMS 1Hz
Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 1Hz on dorsolateral prefrontal cortex (1Hz rTMS is describe in the literature to have no effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter . Heart rate measure With electrocardiogram
干预措施: electrocardiogram (Device)
rTMS 10Hz
Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 10Hz on dorsolateral prefrontal cortex (10Hz rTMS is describe in the literature to have effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter. Heart rate measure with electrocardiogram
干预措施: rTMS 10Hz (Device)
rTMS 10Hz
Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 10Hz on dorsolateral prefrontal cortex (10Hz rTMS is describe in the literature to have effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter. Heart rate measure with electrocardiogram
干预措施: psychoneurological assessment (Behavioral)
rTMS 10Hz
Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 10Hz on dorsolateral prefrontal cortex (10Hz rTMS is describe in the literature to have effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter. Heart rate measure with electrocardiogram
干预措施: conductivity meter (Device)
rTMS 10Hz
Subjects have 8 session of trauma exposure with repeated transcranial magnetic stimulation (rTMS) at 10Hz on dorsolateral prefrontal cortex (10Hz rTMS is describe in the literature to have effect on the dorsolateral prefrontal cortex). psychoneurological assessment. Electrodermal conductance measure With conductivity meter. Heart rate measure with electrocardiogram
干预措施: electrocardiogram (Device)
结局指标
主要结局
Change from baseline Score at Clinician administered PTSD scale
时间窗: inclusion ; 1 months; 3 months
Score at Clinician administered PTSD scale
次要结局
- Change from baseline heart rate(inclusion ; 1day ; 1 month, 3 months)
- Change from baseline Score at PTSD Checklist (self-assessment)(inclusion ; 1 month; 3 months)
- Adverse effect(inclusion ; 1day ; 1 month, 3 months)
- Change from baseline Score at PTSD Checklist (self-assessment) for different dimensions of PTSD(inclusion ; 1 month; 3 months)
- Change from baseline Score at anxiety and depression item on Hamilton Anxiety Rating Scale (HAM-A)(inclusion ; 1 month; 3 months)
- Change from baseline Score at depression item on Hamilton Anxiety Rating Scale (HAM-A)(inclusion ; 1 month; 3 months)
- Change from baseline electrodermal conductance(inclusion ; 1day ; 1 month, 3 months)