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| ID | Type | Description | Link |
|---|---|---|---|
| V12-01578 | Other Identifier | Vancouver Coastal Health Research Institute |
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| Name | Class |
|---|---|
| Vancouver Coastal Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-frequency (1 Hz) rTMS | Active Comparator | 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 (10 Hz) rTMS | Active Comparator | 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 rTMS | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rTMS | Device | Magstim Super Rapid-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Endpoint (treatment end) (Week 2). |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Endpoint (Week 2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry Ong, MD, FRCPC | Vancouver Coastal Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40365001 | Derived | Rayani K, Grabovac A, Chan P, Montgomery S, Ghovanloo MR, Sacchet MD. Brain stimulation enhances dispositional mindfulness in PTSD: an exploratory sham-controlled rTMS trial. Front Psychiatry. 2025 Apr 29;16:1494567. doi: 10.3389/fpsyt.2025.1494567. eCollection 2025. |
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46 patients were assessed for eligibility. 15 were excluded: 7 did not meet inclusion criteria and 8 declined to participate. The remaining 31 patients were enrolled and randomized to one of three conditions.
Participants were recruited from the psychiatry outpatient and community programs of Vancouver Coastal Health between 2014 and 2018. Some participants were recruited after attending an outpatient psychoeducation group but had not received formal group therapy. All assessments and treatments took place at Vancouver General Hospital in Vancouver, British Columbia, Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. rTMS: Magstim Super Rapid-2 |
| FG001 | 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. rTMS: Magstim Super Rapid-2 |
| FG002 | 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. rTMS: Magstim Super Rapid-2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. rTMS: Magstim Super Rapid-2 |
| BG001 | High-frequency (10 Hz) rTMS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intention-to-treat population analysed. | Posted | Mean | Standard Deviation | units on a scale | Endpoint (treatment end) (Week 2). |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-frequency (1 Hz) rTMS | Low-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | MedDRA 10.0 | Non-systematic Assessment |
Several limitations to this study should be highlighted. The sample size was limited and retention within the sham treated group further limited statistical power, which increases the possibility of both type 1 and type 2 error.
We did not verify the integrity of blinding, and we did not use imaging to define treatment targets. These are methodological considerations that should be included in future studies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kawai Leong, MD, MSc, FRCPC | Vancouver Coastal Health / Vancouver General Hospital | 604-875-8289 | kawai.leong@vch.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 10, 2012 | Aug 7, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| 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). | Endpoint (Week 2) |
| 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. | Endpoint (Week 2) |
| 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. | Endpoint (Week 2) |
| 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. | Endpoint (Week 2) |
| Protocol Violation |
|
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. rTMS: Magstim Super Rapid-2 |
| BG002 | 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. rTMS: Magstim Super Rapid-2 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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*8=136, with higher scores indicating more severe symptoms. | Mean | Standard Deviation | units on a scale |
|
| OG001 | High-frequency (10 Hz) rTMS | High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2 |
| OG002 | Sham rTMS | Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2 |
|
|
|
| Secondary | 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". | Intention-to-treat population analysed. | Posted | Mean | Standard Deviation | score on a scale | Endpoint (Week 2). |
|
|
|
|
| Secondary | 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). | Intent-to-treat population analysed. | Posted | Mean | Standard Deviation | score on a scale | Endpoint (Week 2) |
|
|
|
|
| Secondary | 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. | Intent-to-treat population analysed. | Posted | Mean | Standard Deviation | score on a scale | Endpoint (Week 2) |
|
|
|
|
| Secondary | 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. | Intent-to-treat population analysed. | Posted | Mean | Standard Deviation | score on a scale | Endpoint (Week 2) |
|
|
|
|
| Secondary | 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. | Intent-to-treat population. | Posted | Mean | Standard Deviation | score on a scale | Endpoint (Week 2) |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | High-frequency (10 Hz) rTMS | High-frequency active stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2 | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Sham rTMS | Sham stimulation over the right DLPFC on 5 consecutive days every week for 2 weeks, for a total of 10 therapy sessions, with 37.5 minutes per session. rTMS: Magstim Super Rapid-2 | 0 | 9 | 0 | 9 | 0 | 9 |
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| Male |
|