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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roumen Milev, Queen's University
ClinicalTrials.gov Identifier:
NCT00685152
First received: May 8, 2008
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

Resource links provided by NLM:

U.S. FDA Resources

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 version(1) [ 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: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: 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
Study First Received: May 8, 2008
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada
Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013