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临床试验/NCT01196624
NCT01196624已完成2 期

Efficacy of Repetitive Transcranial Magnetic Stimulation Right Versus Left, With or Without Traumatic Stimuli in the Treatment of Posttraumatic Stress Disorder (PTSD) and Its Flashbacks

Beersheva Mental Health Center1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2008年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
flashback severity, CAPS score

研究概览

简要总结

Subjects

Forty consecutive patients fulfilling the DSM-IV diagnostic criteria for PTSD will be recruited from the inpatient and outpatient treatment programs at the Beer Sheva Mental Health Center. Patients will complet a course of 10 daily rTMS sessions.

After receiving a full explanation of the procedures, all subjects will sign a written informed consent statement approved by the Helsinki Ethics Committee of Ben-Gurion University.

Study Design

The study suggested here will recruit 40 patients with DSM-IV PTSD also demonstrating at least moderately severe flashbacks. Each of the subjects will be recruited randomly to one of 4 groups:

  1. Right DLPF Rtms (10Hz) co-administered with neutral visual and/or auditori stimuli;
  2. Right DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli mimicking experiences appearing during the patients flashbacks;
  3. Left DLPF Rtms (10Hz) co-administered with neutral visual and or auditori stimuli;
  4. Left DLPF Rtms (10Hz) co-administered with visual and/or auditori traumatic stimuli mimicking experiences appearing during the patients flashbacks;

Treatment Characteristics

rTMS will be performed with a Magstim stimulator (Magstim Company, Whitland, U.K.) The motor threshold was determined in each subject once, before treatment. This was defined as the lowest stimulation intensity capable of inducing a visible movement at least five times out of 10 stimulations.

The position of the right dorsolateral prefrontal cortex will be defined as 5 cm anterior (in a parasagittal line) to the motor cortex. The stimulus intensity will be 80% of the patient's motor threshold intensity.

Treatments will be given for 20 minutes per day over 10 working days. Both subjects received high-frequency rTMS) received 10 Hz for 2 seconds per train; the intertrain interval was 58 seconds. For each participant the stimulus was administered over the right dorsolateral prefrontal cortex.

Rating Scales

The ratings of PTSD symptoms, anxiety, and depression willm be carried out by an expert investigator who will be blind to the stimulation condition. The patients will be assessed at four time points-before TMS (baseline), at day 5, at day 10, and at day 24 (14 days after the intervention). The instruments used will be as follows:

The PTSD Checklist The Treatment Outcome PTSD Scale The Hamilton Anxiety Rating Scale The Hamilton Rating Scale for Depression PTSD symptoms were assessed by using the Hebrew version of the Clinician-Administered PTSD Scale.

详细描述

Subjects

Forty consecutive patients fulfilling the DSM-IV diagnostic criteria for PTSD (as assessed by the Structured Clinical Interview) will be recruited from the inpatient and outpatient treatment programs at the Beer Sheva Mental Health Center. Patients will complet a course of 10 daily rTMS sessions.

The exclusion criteria includ: substance use disorder, cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma. Patients suffering from chronic medical conditions of any sort will be excluded from the study.

After receiving a full explanation of the procedures, all subjects will sign a written informed consent statement approved by the Helsinki Ethics Committee of Ben-Gurion University.

Study Design

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

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

入选标准

  • Consecutive patients fulfilling the DSM-IV diagnostic criteria for PTSD (as assessed by the Structured Clinical Interview) will be recruited from the inpatient and outpatient treatment programs at the Beer Sheva Mental Health Center.

排除标准

  • The exclusion criteria includ:
  • substance use disorder, cardiac pacemaker implant, or a history of epilepsy, neurosurgery, or brain trauma.
  • Patients suffering from chronic medical conditions of any sort will be excluded from the study.

结局指标

主要结局

flashback severity, CAPS score

时间窗: the study will be held for 1-2 years

次要结局

未报告次要终点

研究者

发起方
Beersheva Mental Health Center
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Joseph Levine

MD, psychiatrist

Beersheva Mental Health Center

研究点 (1)

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