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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685152
• Other study ID #: psiy-267-07
• Status: Completed
• Phase: N/A
• First received: May 8, 2008
• Last updated: December 14, 2015
• Start date: January 2008
• Est. completion date: November 2012

Study information

• Verified date: December 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
Bulgaria	Dr. Dancho Dilkov	Sofia
Canada	Providence Care Mental Health Services	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Countries where clinical trial is conducted

Bulgaria,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS) in both active and sham groups		pre, week 2,4,6,8 & 12	No
Secondary	Treatment Outcome PTSD scale (TOP-8)		Pre, week 2,4,6,8 & 12	No
Secondary	Hamilton Anxiety Scale		Pre, week 2,4,6,8 & 12	No
Secondary	Hamilton Depression Rating Scale		Pre, week 2,4,6,8 & 12	No
Secondary	Clinical Global Impression Scale (both severity and improvement)		Pre, week 2,4,6,8 & 12	No
Secondary	Social Functioning-36 Quality of Life Scale version(1)		Pre, week 2,4,6,8 & 12	No
Secondary	Pittsburgh Sleep Quality Index		Pre, week 2,4,6,8 & 12	No
Secondary	PTSD Checklist-civilian (PCL-C)		Pre, week 2,4,6,8 & 12	No