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Completed

NCT Number: NCT00685152

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.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Dancho Dilkov, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: rTMS machine (MagPro, Medtronic).

Primary outcomes

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

    Time frame: pre, week 2,4,6,8 & 12

Secondary outcomes

  1. Treatment Outcome PTSD scale (TOP-8)

    Time frame: Pre, week 2,4,6,8 & 12

  2. Hamilton Anxiety Scale

    Time frame: Pre, week 2,4,6,8 & 12

  3. Hamilton Depression Rating Scale

    Time frame: Pre, week 2,4,6,8 & 12

  4. Clinical Global Impression Scale (both severity and improvement)

    Time frame: Pre, week 2,4,6,8 & 12

  5. Social Functioning-36 Quality of Life Scale version(1)

    Time frame: Pre, week 2,4,6,8 & 12

  6. Pittsburgh Sleep Quality Index

    Time frame: Pre, week 2,4,6,8 & 12

  7. PTSD Checklist-civilian (PCL-C)

    Time frame: Pre, week 2,4,6,8 & 12

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 28, 2008
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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