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

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PTSD diagnosis per DSM IV

Exclusion Criteria:

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

Sites / Locations

  • Psychiatric department, Hadassah-Hebrew universityMedical Organization

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Exposure-Stimulation

Sham exposure - Real stimulation

Exposure - Sham Stimulation

Arm Description

Outcomes

Primary Outcome Measures

CAPS SCORE [TOTAL, INTRUSION]

Secondary Outcome Measures

Full Information

First Posted
August 16, 2007
Last Updated
April 19, 2015
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00517400
Brief Title
Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder
Official Title
Evaluation of the H-Coil Transcranial Magnetic Stimulation (TMS) Device- Treatment for Post Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure-Stimulation
Arm Type
Active Comparator
Arm Title
Sham exposure - Real stimulation
Arm Type
Active Comparator
Arm Title
Exposure - Sham Stimulation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Deep repetitive Transcranial Magnetic Stimulation (rTMS) real or sham
Other Intervention Name(s)
Brainsway H-Coil
Primary Outcome Measure Information:
Title
CAPS SCORE [TOTAL, INTRUSION]
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PTSD diagnosis per DSM IV Exclusion Criteria: Schizophrenia Bipolar I severe Axis II diagnosis risk factors to convulsions drug / alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Isserles, MD, MSc
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric department, Hadassah-Hebrew universityMedical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
22921765
Citation
Isserles M, Shalev AY, Roth Y, Peri T, Kutz I, Zlotnick E, Zangen A. Effectiveness of deep transcranial magnetic stimulation combined with a brief exposure procedure in post-traumatic stress disorder--a pilot study. Brain Stimul. 2013 May;6(3):377-83. doi: 10.1016/j.brs.2012.07.008. Epub 2012 Aug 18.
Results Reference
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Deep Transcranial Magnetic Stimulation (TMS)- Treatment for Post Traumatic Stress Disorder

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