Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Queen's University.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014