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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00517400
First received: August 16, 2007
Last updated: July 27, 2011
Last verified: July 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • CAPS SCORE [TOTAL, INTRUSION]

Enrollment: 30
Study Start Date: February 2008
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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)
Study First Received: August 16, 2007
Last Updated: July 27, 2011
Health Authority: Israel: Ministry of Health, Health Technology and Infrastructure Administration, Medical Device Department

Keywords provided by Hadassah Medical Organization:
PTSD

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

ClinicalTrials.gov processed this record on May 23, 2013