rTMS in the Treatment of PTSD

March 21, 2021 updated by: Peter Y Chan, University of British Columbia

The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder

The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an effect on symptoms of PTSD compared to sham rTMS treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary diagnosis of PTSD as determined by a structured interview using the Mini International Neuropsychiatric Interview (MINI)
  • no change in psychotropic medications within 4 weeks before the start of rTMS
  • age > 19 years and < 70 years
  • competency to give informed consent

Exclusion Criteria:

  • any non-fixed metal object or implant (including cochlear implants) in brain, skull, scalp, or neck within 30 cm of the magnetic rTMS coil
  • implantable devices, including cardiac pacemakers and defibrillators
  • other contraindications to rTMS, including history of seizures (except childhood febrile seizures) or recent and unexplained syncope, first-degree relative with a history of epilepsy, treatment with a medication known to substantially decrease the seizure threshold, or pregnancy
  • psychiatric diagnoses of psychosis or psychotic disorder (including psychotic depression), bipolar type I disorder, or organic mental disorders
  • substance abuse/dependence within the past 3 months
  • active suicidal risk as judged by the clinician
  • borderline or antisocial personality disorder
  • acute medical illness, including cancer
  • any significant central nervous system disorder, such as brain mass, stroke, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low-frequency (1 Hz) rTMS
Low-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.
Device: rTMS
Magstim Super Rapid-2
Other Names:
  • repetitive transcranial magnetic stimulation
Active Comparator: High-frequency (10 Hz) rTMS
High-frequency active stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.
Device: rTMS
Magstim Super Rapid-2
Other Names:
  • repetitive transcranial magnetic stimulation
Placebo Comparator: Sham rTMS
Sham stimulation over the right dorsolateral prefrontal cortex (DLPFC) on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session.
Device: rTMS
Magstim Super Rapid-2
Other Names:
  • repetitive transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
Time Frame: Endpoint (treatment end) (Week 2).
The Clinician-Administered PTSD Scale-IV (CAPS-IV) is a semi-structured instrument that assesses the intensity, frequency, and severity of PTSD symptoms. It consists of 17 symptom items, each rated on a 0-4 scale for frequency and a 0-4 scale for intensity, with higher scores indicating greater frequency/intensity. The frequency and intensity scores are then summed to yield a total item severity score (range 0-8). The minimum score of the overall scale is 0 and maximum is 17 items * maximum severity score of 8 = 136 (higher scores indicating more severe symptoms).
Endpoint (treatment end) (Week 2).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Checklist for Civilians (PCL-C)
Time Frame: Endpoint (Week 2).
The PTSD Checklist for Civilians (PCL-C) is a standardised self-report rating scale for PTSD comprising 17 items that correspond to the DSM-V symptoms of PTSD. A total symptom severity score (range = 17-85) can be obtained by summing the scores from each of the 17 items that have response options ranging from 1 "Not at all" to 5 "Extremely".
Endpoint (Week 2).
Hamilton Depression Rating Scale, 21-item Version (HDRS-21)
Time Frame: Endpoint (Week 2)
A clinician-rated assessment of depression symptoms consisting of 21 items rated on a scale from 0 to 4, 0 to 2, or 0 to 3, with higher scores indicating greater symptom severity in all cases. Minimum score = 0; maximum score = 53 (scores > 23 are considered to be severe).
Endpoint (Week 2)
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Time Frame: Endpoint (Week 2)
A self-report scale to assess symptoms of depression consisting of 16 items, 9 of which contribute to a summed total score (i.e., only the highest score of items 1-4, 6-9, and 15-16 are counted). Scores range from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-27, with scores >= 21 considered very severe, 20-16 severe, 11-15 moderate, and 6-10 mild depression.
Endpoint (Week 2)
Beck Anxiety Inventory (BAI)
Time Frame: Endpoint (Week 2)
A self-report scale to assess symptoms of anxiety, consisting of 21 items scored on a scale from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-63, with scores >= indicating potentially concerning levels of anxiety.
Endpoint (Week 2)
Generalized Anxiety Disorder (GAD-7) Scale
Time Frame: Endpoint (Week 2)
A brief self-report scale to assess symptoms of anxiety, consisting of 7 items each scored on a scale from 0-3, with higher scores indicating more severe symptoms. Total scores range from 0-21, with scores 0-4 suggesting minimal anxiety, 5-9 mild, 10-14 moderate, and 15-21 severe anxiety.
Endpoint (Week 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

Vancouver Coastal Health

Investigators

  • Principal Investigator: Larry Ong, MD, FRCPC, Vancouver Coastal Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-01578
  • V12-01578 (Other Identifier: Vancouver Coastal Health Research Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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