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Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

NCT ID: NCT00134446

Last Updated: 2005-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Brief Summary

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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

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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.

Conditions

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Post-Traumatic Stress Disorders

Keywords

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post traumatic stress disorder PTSD trauma transcranial magnetic stimulation randomized clinical trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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transcranial magnetic stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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White River Junction Veterans Affairs Medical Center

FED

Sponsor Role lead

Principal Investigators

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Bradley V Watts, MD

Role: PRINCIPAL_INVESTIGATOR

White River Junction Veterans Affairs Medical Center

Locations

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White River Junction VAMC

White River Junction, Vermont, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bradley V Watts, MD

Role: CONTACT

Phone: 802-295-9363

Email: [email protected]

Facility Contacts

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Bradley V Watts, MD

Role: primary

Other Identifiers

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Hitchcock Foundation

Identifier Type: -

Identifier Source: secondary_id

WRJVAMC16744

Identifier Type: -

Identifier Source: org_study_id