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

May 8, 2008
March 15, 2012
January 2008
November 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00685152 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)
High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
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).
  • Experimental: Active rTMS
    Repetitive Transcranial Magnetic Stimulation
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)
  • Sham Comparator: 2
    Device: Sham (placebo)
    Intervention: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
November 2012
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada
 
NCT00685152
psiy-267-07
No
Roumen Milev, Queen's University
Queen's University
Not Provided
Principal Investigator: Roumen Milev, MD Queen's University
Queen's University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP