High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD

NCT ID: NCT02873299

Last Updated: 2016-08-22

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

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)

Detailed Description

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This is a randomized single-blind pilot study investigating the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex at either 10 Hz or 20 Hz as compared to a treatment as usual group for the treatment of Post Traumatic Stress Disorder (PTSD) symptoms.

Conditions

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PTSD, Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment as usual

Treatment as usual, wait list control group

Group Type NO_INTERVENTION

No interventions assigned to this group

rTMS at 10Hz

10 Hz rTMS of the right dorsolateral prefrontal cortex

Group Type ACTIVE_COMPARATOR

10 Hz rTMS of the right dorsolateral prefrontal cortex

Intervention Type OTHER

Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex

rTMS at 20Hz

20 Hz rTMS of the right dorsolateral prefrontal cortex

Group Type ACTIVE_COMPARATOR

20 Hz rTMS of the right dorsolateral prefrontal cortex

Intervention Type OTHER

Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex

Interventions

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10 Hz rTMS of the right dorsolateral prefrontal cortex

Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex

Intervention Type OTHER

20 Hz rTMS of the right dorsolateral prefrontal cortex

Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Willing and able to give informed consent
* Diagnosis of Post-Traumatic Stress Disorder as determined by the SCID
* CAPS score of at least 40
* Males or females between 18-65 years of age
* Willing to give up new psychotherapy or changes in psychiatric medications during the course of the TMS treatment.

Exclusion Criteria

* Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder
* Patients with HDRS score ≥ 18
* A metallic implant in cranium (except the mouth)
* Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety
* ECT treatment within the last three months
* Patients with a history of epilepsy
* Patients with neurological disorder leading to increased intracranial pressure
* Participation in a new course of psychotherapy during the 24 days of the study
* A new psychiatric medication within 6 weeks of enrolling in the study
* Changes in psychiatric medication within 2 weeks of starting the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Naval Medical Center, San Diego

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc A Capobianco, MD, DFAPA

Role: PRINCIPAL_INVESTIGATOR

NMCSD

Locations

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NMCSD

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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NMCSD.2011.0025

Identifier Type: -

Identifier Source: org_study_id

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