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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Dr. Dancho Dilkov
• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 4X3
      • Providence Care Mental Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: rTMS machine (MagPro, Medtronic).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinician Administered PTSD Scale (CAPS) in both active and sham groups	pre, week 2,4,6,8 & 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Queen's University

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: May 8, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: psiy-267-07