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NCT ID: NCT01196624 Completed - Clinical trials for Posttraumatic Stress Disorder

Repetitive Transcranial Magnetic Stimulation With Or Without Traumatic Stimuli in Post Traumatic Stress Disorder (PTSD)

BSPTSDTMS2010
Start date: November 2008
Phase: Phase 2
Study type: Interventional

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.