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

Not Applicable

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)

• Registration Number: NCT00685152
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)	Device: Sham (placebo)
Active rTMS	Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)	Repetitive Transcranial Magnetic Stimulation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale	Pre, week 2,4,6,8 & 12
Treatment Outcome PTSD scale (TOP-8)	Pre, week 2,4,6,8 & 12
Hamilton Anxiety Scale	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
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

Trial Locations

Locations (2)

Providence Care Mental Health Services; 🇨🇦 Kingston, Ontario, Canada

Dr. Dancho Dilkov; 🇧🇬 Sofia, Bulgaria