Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder
Primary Purpose
Post-Traumatic Stress Disorders
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorders focused on measuring post traumatic stress disorder, PTSD, trauma, transcranial magnetic stimulation, randomized clinical trial
Eligibility Criteria
Inclusion Criteria: PTSD diagnosis on standardized assessment Medically stable Eligible veteran of United States (US) military Exclusion Criteria: Active substance abuse History of seizures Metal in head or neck
Sites / Locations
- White River Junction VAMCRecruiting
Outcomes
Primary Outcome Measures
Clinician-Administered PTSD Scale (CAPS)
Secondary Outcome Measures
PTSD Clinician Checklist (PCL)
Beck Depression Inventory (BDI)
State-Trait Anxiety Inventory (STAI)
Side Effect Checklist
Brief Cognitive Examination
Full Information
NCT ID
NCT00134446
First Posted
August 23, 2005
Last Updated
October 28, 2005
Sponsor
White River Junction Veterans Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00134446
Brief Title
Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder
Official Title
A Prospective Double Blind Randomized Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
White River Junction Veterans Affairs Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if transcranial magnetic stimulation at 1 HZ to the right frontal cortex will decrease the symptoms of post-traumatic stress disorder (PTSD).
Detailed Description
Post-traumatic stress disorder (PTSD) is a psychiatric disorder that is common in the general population. PTSD symptoms include re-experiencing the traumatic event, avoidance of reminders of the trauma, and increased arousal. The primary treatments of PTSD are psychotherapy and antidepressant medications. While both are effective, many patients continue to have significant symptoms. Repetitive Transcranial Magnetic Stimulation (rTMS) is a new research and treatment modality that uses a small powerful electromagnet to directly stimulate the brain. This stimulation may increase or decrease brain activity. The treatments have been shown to be effective in other disorders such as depression. Initial treatment of patients with PTSD using rTMS has been hopeful. This study is the first randomized controlled trial to examine the efficacy of rTMS for PTSD.
This study would be the first randomized placebo controlled trial to examine the efficacy of Transcranial Magnetic Stimulation (rTMS) for PTSD. The primary hypothesis is that there will be significant improvement in the patients' PTSD symptoms from pre-treatment to post-treatment with rTMS. A secondary hypothesis is that the patients' co-morbid depressive symptoms will improve from pre-treatment to post-treatment. Forty subjects with PTSD will be recruited from the White River Junction VAMC. Patients will be randomly assigned to receive either active rTMS or sham rTMS. Patients, staff performing the treatments, and staff completing the assessments will all be blinded to active or sham treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorders
Keywords
post traumatic stress disorder, PTSD, trauma, transcranial magnetic stimulation, randomized clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale (CAPS)
Secondary Outcome Measure Information:
Title
PTSD Clinician Checklist (PCL)
Title
Beck Depression Inventory (BDI)
Title
State-Trait Anxiety Inventory (STAI)
Title
Side Effect Checklist
Title
Brief Cognitive Examination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
PTSD diagnosis on standardized assessment
Medically stable
Eligible veteran of United States (US) military
Exclusion Criteria:
Active substance abuse
History of seizures
Metal in head or neck
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bradley V Watts, MD
Phone
802-295-9363
Ext
5688
Email
bradley.v.watts@dartmouth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley V Watts, MD
Organizational Affiliation
White River Junction Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
White River Junction VAMC
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley V Watts, MD
Phone
802-295-9363
Ext
5688
Email
bradley.v.watts@dartmouth.edu
First Name & Middle Initial & Last Name & Degree
Bradley V Watts, MD
12. IPD Sharing Statement
Learn more about this trial
Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder
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