Repetitive Transcranial Magnetic Stimulation With Or Without Traumatic Stimuli in Post Traumatic Stress Disorder (PTSD) (BSPTSDTMS2010)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Levine, Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT01196624
First received: June 28, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Flashbacks
Posttraumatic Stress Disorder
Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULI
Device: rapid TMS, EXPOSURE
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • flashback severity, CAPS score [ Time Frame: the study will be held for 1-2 years ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: November 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TMS TO RT DLPF WITH EXPOSURE
TMS TO RIGHT PREFRONTAL DORSOLATERAL BRAIN AREA WITH EXPOSURE
Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULI
RAPID TMS, EXPOSURE TO TRAUMATIC STIMULI
Device: rapid TMS, EXPOSURE
apid TMS, EXPOSURE
Active Comparator: TMS TO RIGHT DLPF BRAIN AREA WITHOUT EXPOSURE
TMS TO RIGHT DLPF BRAIN AREA WITHOUT EXPOSURE
Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULI
RAPID TMS, EXPOSURE TO TRAUMATIC STIMULI
Device: rapid TMS, EXPOSURE
apid TMS, EXPOSURE
Active Comparator: TMS TO LEFT PREFRONTAL DORSOLATERAL BRAIN AREA WITH EXPOSURE
TMS TO LEFT PREFRONTAL DORSOLATERAL BRAIN AREA WITH EXPOSURE
Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULI
RAPID TMS, EXPOSURE TO TRAUMATIC STIMULI
Device: rapid TMS, EXPOSURE
apid TMS, EXPOSURE
Active Comparator: TMS TO LEFT DLPF BRAIN AREA WITHOUT EXPOSURE
TMS TO LEFT DLPF BRAIN AREA WITHOUT EXPOSURE
Device: rapid TMS, EXPOSURE TO TRAUMATIC STIMULI
RAPID TMS, EXPOSURE TO TRAUMATIC STIMULI
Device: rapid TMS, EXPOSURE
apid TMS, EXPOSURE

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

Subjects

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196624

Locations
Israel
Beersheva mental Health Center
Beersheva,, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Investigators
Principal Investigator: Joseph Levine, Associate Professor Beersheva mental Health Center, Israel
Principal Investigator: Nimrod Grisaru Beersheva Mental Health Center
  More Information

No publications provided

Responsible Party: Joseph Levine, MD, psychiatrist, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT01196624     History of Changes
Other Study ID Numbers: BeershevaMHC - 4733CTIL
Study First Received: June 28, 2010
Last Updated: February 5, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Beersheva Mental Health Center:
PTSD
FLASHBACKS
TMS
EXPOSURE

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014