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High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

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ClinicalTrials.gov Identifier: NCT00685152
Recruitment Status : Completed
First Posted : May 28, 2008
Last Update Posted : December 16, 2015
Sponsor:
Information provided by (Responsible Party):
Dr. Roumen Milev, Queen's University

Brief Summary:
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 or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)
Study Start Date : January 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active rTMS
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.
Other Name: rTMS machine (MagPro, Medtronic).
Sham Comparator: 2
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.
Other Name: rTMS machine (MagPro, Medtronic).



Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS) in both active and sham groups [ Time Frame: pre, week 2,4,6,8 & 12 ]

Secondary Outcome Measures :
  1. Treatment Outcome PTSD scale (TOP-8) [ Time Frame: Pre, week 2,4,6,8 & 12 ]
  2. Hamilton Anxiety Scale [ Time Frame: Pre, week 2,4,6,8 & 12 ]
  3. Hamilton Depression Rating Scale [ Time Frame: Pre, week 2,4,6,8 & 12 ]
  4. Clinical Global Impression Scale (both severity and improvement) [ Time Frame: Pre, week 2,4,6,8 & 12 ]
  5. Social Functioning-36 Quality of Life Scale version(1) [ Time Frame: Pre, week 2,4,6,8 & 12 ]
  6. Pittsburgh Sleep Quality Index [ Time Frame: Pre, week 2,4,6,8 & 12 ]
  7. PTSD Checklist-civilian (PCL-C) [ Time Frame: Pre, week 2,4,6,8 & 12 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 or if they are taking PTSD pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase.
  • Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685152


Locations
Bulgaria
Dr. Dancho Dilkov
Sofia, Bulgaria
Canada, Ontario
Providence Care Mental Health Services
Kingston, Ontario, Canada, K7L 4X3
Sponsors and Collaborators
Queen's University
Investigators
Principal Investigator: Roumen Milev, MD Queen's University

Responsible Party: Dr. Roumen Milev, Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University, Queen's University
ClinicalTrials.gov Identifier: NCT00685152     History of Changes
Other Study ID Numbers: psiy-267-07
First Posted: May 28, 2008    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders