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Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT00517400
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : April 21, 2015
Sponsor:
Information provided by:
Hadassah Medical Organization

Brief Summary:

Evaluation of the novel deep TMS H-Coil designs as a treatment measure in post traumatic stress disorder (PTSD).

Comparing real to sham treatment.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder
Study Start Date : February 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Exposure-Stimulation Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Other Name: Brainsway H-Coil
Active Comparator: Sham exposure - Real stimulation Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Other Name: Brainsway H-Coil
Active Comparator: Exposure - Sham Stimulation Device: Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Other Name: Brainsway H-Coil



Primary Outcome Measures :
  1. CAPS SCORE [TOTAL, INTRUSION] [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PTSD diagnosis per DSM IV

Exclusion Criteria:

  • Schizophrenia
  • Bipolar I
  • severe Axis II diagnosis
  • risk factors to convulsions
  • drug / alcohol abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517400


Locations
Israel
Psychiatric department, Hadassah-Hebrew universityMedical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Moshe Isserles, MD, MSc Hadassah Medical Organization

Publications of Results:
Responsible Party: Moshe Isserles, MD, MSc, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00517400     History of Changes
Other Study ID Numbers: 364/3.8.07(HMO)
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: July 2010

Keywords provided by Hadassah Medical Organization:
PTSD

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders