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

NCT00685152 | Completed

• 1 other identifier: psiy-267-07
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale (CAPS) in both active and sham groups

  pre, week 2,4,6,8 & 12

Secondary Outcomes (7)

• 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

Study Arms (2)

Active rTMS

EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation

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

2

SHAM COMPARATOR

Device: Sham (placebo)

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

Interventions

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

Also known as: rTMS machine (MagPro, Medtronic).

2; Active rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (2)

Dr. Dancho Dilkov

Sofia, Bulgaria

Location

Providence Care Mental Health Services

Kingston, Ontario, K7L 4X3, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Roumen Milev, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University

Study Record Dates

• First Submitted: May 8, 2008
• First Posted: May 28, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 16, 2015

Record last verified: 2015-12

Locations

BU (1); CA (1)