High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-Traumatic Stress Disorder (PTSD) - Full Text View

Purpose

This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD Scale (CAPS) in both active and control groups.

Condition	Intervention
Post-Traumatic Stress Disorder	Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)

MedlinePlus related topics:

Anxiety Post-Traumatic Stress Disorder Stress

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-Traumatic Stress Disorder (PTSD)

Further study details as provided by Queen's University:

Primary Outcome Measures:

Clinician Administered PTSD Scale (CAPS) in both active and sham groups [ Time Frame: pre, week 2,4,6,8 & 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment Outcome PTSD scale (TOP-8) [ Time Frame: Pre, week 2,4,6,8 & 12 ] [ Designated as safety issue: No ]
Hamilton Anxiety Scale [ Time Frame: Pre, week 2,4,6,8 & 12 ] [ Designated as safety issue: No ]
Hamilton Depression Rating Scale [ Time Frame: Pre, week 2,4,6,8 & 12 ] [ Designated as safety issue: No ]
Clinical Global Impression Scale (both severity and improvement) [ Time Frame: Pre, week 2,4,6,8 & 12 ] [ Designated as safety issue: No ]
Social Functioning-36 Quality of Life Scale [ Time Frame: Pre, week 2,4,6,8 & 12 ] [ Designated as safety issue: No ]
Pittsburgh Sleep Quality Index [ Time Frame: Pre, week 2,4,6,8 & 12 ] [ Designated as safety issue: No ]
PTSD Checklist-civilian (PCL-C) [ Time Frame: Pre, week 2,4,6,8 & 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	January 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active rTMS: Experimental Repetitive Transcranial Magnetic Stimulation	Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic) 6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic.
2: Sham Comparator Device: Sham (placebo)	Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic) 6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Patient Information and Consent.
Patients with primary Post-Traumatic Stress Disorder (as diagnosed by MINI) and DSM IV TR.
Patients with CAPS score of at least 40.
Males or females between 18-65 years of age.
Patients not taking PTSD pharmacotherapy for at least last 2 weeks prior to commencing in the study.

Exclusion Criteria:

Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder.
Other primary Axis I disorders which, in the opinion of the investigator, may affect the outcome of this study.
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.
Patients with severe cardiac disorder or intracardiac lines and pacemakers.
Patients with current suicide risk ≥ 6 points by MINI.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685152

Contacts


Contact: Roumen Milev, MD	613-548-5567 ext 5823	milevr@providencecare.ca

Contact: Shea Ann, RN	613-548-5567 ext 5898	sheaa@providencecare.ca

Locations


Bulgaria
	Dr. Dancho Dilkov	Recruiting
	Sofia, Bulgaria

Canada, Ontario
	Providence Care Mental Health Services	Recruiting
	Kingston, Ontario, Canada, K7L 4X3
	Contact: Ann Shea, Reg. N 613-548-5567 ext 5898 sheaa@providencecare.ca
	Sub-Investigator: Alan Lowe, MD
	Sub-Investigator: Ruzica Jokic, MD
	Sub-Investigator: Regina duToit, MD

Sponsors and Collaborators

Queen's University

Investigators


Principal Investigator:	Roumen Milev, MD	Queen's University

More Information

Responsible Party:	Queen's University ( Dr. Roumen Milev )
Study ID Numbers:	psiy-267-07
First Received:	May 8, 2008
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00685152
Health Authority:	Canada: Health Canada; Bulgaria: Bulgarian Drug Agency

Study placed in the following topic categories:

Anxiety Disorders

Mental Disorders

Stress Disorders, Post-Traumatic

Stress

Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes

Disease

ClinicalTrials.gov processed this record on November 05, 2008

Sponsored by:	Queen's University
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00685152