Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

Post-Traumatic Stress Disorders Clinical Trial

Official title:

A Prospective Double Blind Randomized Placebo Controlled Trial of Repetitive Transcranial Magnetic Stimulation for Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00134446
• Other study ID #: WRJVAMC16744
• Secondary ID: Hitchcock Founda
• Status: Recruiting
• Phase: Phase 4
• First received: August 23, 2005
• Last updated: October 28, 2005
• Start date: March 2004

Study information

• Verified date: March 2005
• Source: White River Junction VAMC
• Contact: Bradley V Watts, MD
• Phone: 802-295-9363
• Email: bradley.v.watts[@]dartmouth.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• transcranial magnetic stimulation

Locations

Country	Name	City	State
United States	White River Junction VAMC	White River Junction	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
White River Junction VAMC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale (CAPS)
Secondary	PTSD Clinician Checklist (PCL)
Secondary	Beck Depression Inventory (BDI)
Secondary	State-Trait Anxiety Inventory (STAI)
Secondary	Side Effect Checklist
Secondary	Brief Cognitive Examination