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

NCT ID: NCT00685152

Last Updated: 2015-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-11-30

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.

Conditions

Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active rTMS

Repetitive Transcranial Magnetic Stimulation

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)

Intervention Type: DEVICE

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.

2

Device: Sham (placebo)

Group Type: SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

rTMS machine (MagPro, Medtronic).

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Roumen Milev

Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roumen Milev, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Dr. Dancho Dilkov

Sofia, , Bulgaria

Providence Care Mental Health Services

Kingston, Ontario, Canada

Countries

Bulgaria; Canada

Other Identifiers

psiy-267-07

Identifier Type: -

Identifier Source: org_study_id