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

PTSD, Post Traumatic Stress Disorder Clinical Trial

— rTMS  

Official title:

High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Post Traumatic Stress Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873299
• Other study ID #: NMCSD.2011.0025
• Status: Completed
• Phase: Phase 0
• First received: September 30, 2014
• Last updated: August 18, 2016
• Start date: April 2012
• Est. completion date: October 2014

Study information

• Verified date: August 2016
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD, Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• 10 Hz rTMS of the right dorsolateral prefrontal cortex
Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex
• 20 Hz rTMS of the right dorsolateral prefrontal cortex
Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex

Locations

Country	Name	City	State
United States	NMCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale , CAPS	The CAPS is the gold-standard, semi-structured interview that corresponds to DSM-IV criteria for PTSD.	day 10	Yes
Secondary	Posttraumatic Stress Disorder Checklist, PCL	The PCL consists of 17 items measured on a 5-point Likert scale ranging from "not at all" to "extremely	week 24	No