Back to resultsrTMS in the Treatment of PTSD
Primary Purpose
Post-traumatic Stress Disorder (PTSD)
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder (PTSD) focused on measuring Post-traumatic stress disorder, Repetitive transcranial magnetic stimulation, Civilians, Neurostimulation, Dorsolateral prefrontal cortex
Eligibility Criteria
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.
Sites / Locations
- Vancouver General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Low-frequency (1 Hz) rTMS
High-frequency (10 Hz) rTMS
Sham rTMS
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
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).
Secondary Outcome Measures
PTSD Checklist for Civilians (PCL-C)
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".
Hamilton Depression Rating Scale, 21-item Version (HDRS-21)
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).
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
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.
Beck Anxiety Inventory (BAI)
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.
Generalized Anxiety Disorder (GAD-7) Scale
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.
Full Information
NCT ID
NCT01806168
First Posted
March 4, 2013
Last Updated
March 21, 2021
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health
1. Study Identification
Unique Protocol Identification Number
NCT01806168
Brief Title
rTMS in the Treatment of PTSD
Official Title
The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder (PTSD)
Keywords
Post-traumatic stress disorder, Repetitive transcranial magnetic stimulation, Civilians, Neurostimulation, Dorsolateral prefrontal cortex
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-frequency (1 Hz) rTMS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
High-frequency (10 Hz) rTMS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Sham rTMS
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
rTMS
Other Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
Magstim Super Rapid-2
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
Description
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).
Time Frame
Endpoint (treatment end) (Week 2).
Secondary Outcome Measure Information:
Title
PTSD Checklist for Civilians (PCL-C)
Description
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".
Time Frame
Endpoint (Week 2).
Title
Hamilton Depression Rating Scale, 21-item Version (HDRS-21)
Description
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).
Time Frame
Endpoint (Week 2)
Title
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Description
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.
Time Frame
Endpoint (Week 2)
Title
Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Endpoint (Week 2)
Title
Generalized Anxiety Disorder (GAD-7) Scale
Description
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.
Time Frame
Endpoint (Week 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Ong, MD, FRCPC
Organizational Affiliation
Vancouver Coastal Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
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rTMS in the Treatment of PTSD
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