Post-traumatic Stress Disorder (PTSD)NCT01806168
rTMS in the Treatment of PTSD
A study testing rTMS in people with Post-traumatic Stress Disorder (PTSD), run by University of British Columbia at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Post-traumatic Stress Disorder (PTSD)
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2013to Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- borderline or antisocial personality disorder
- acute medical illness, including cancer
- any significant central nervous system disorder, such as brain mass, stroke, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Being tested
- rTMS
- Keywords
- Post-traumatic stress disorder, Repetitive transcranial magnetic stimulation, Civilians, Neurostimulation, Dorsolateral prefrontal cortex
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called repetitive transcranial magnetic stimulation
Magstim Super Rapid-2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: rTMS |
| 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. Receives: Device: rTMS |
| 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. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Endpoint (treatment end) (Week 2).
Secondary outcomes (5)
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".
Measured: Endpoint (Week 2).
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Endpoint (Week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Coastal Health
- Responsible party
- Principal investigator, Peter Y Chan, University of British Columbia
- Investigators
- Larry Ong, MD, FRCPC, Principal investigator, Vancouver Coastal Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806168
- Sponsor's protocol ID
- H12-01578
- Other IDs
- V12-01578
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2013
- Last updated
- 14 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 40365001
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT01806168
- Acronym / sponsor ID
- H12-01578
- Conditions
- Post-traumatic Stress Disorder (PTSD)
- Keywords
- Post-traumatic stress disorder, Repetitive transcranial magnetic stimulation, Civilians, Neurostimulation, Dorsolateral prefrontal cortex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Coastal Health
- Study start
- Sep 2013 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 14 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-frequency (1 Hz) rTMS | Active comparator | Device: rTMSLow-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 | Device: rTMSHigh-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 | Device: rTMSSham 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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSAlso: repetitive transcranial magnetic stimulationMagstim Super Rapid-2 | Device | High-frequency (10 Hz) rTMS, Low-frequency (1 Hz) rTMS, Sham rTMS |
Primary outcome
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).
5 secondary outcomes
PTSD Checklist for Civilians (PCL-C)
Time frame: Endpoint (Week 2).
Hamilton Depression Rating Scale, 21-item Version (HDRS-21)
Time frame: Endpoint (Week 2)
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Time frame: Endpoint (Week 2)
Beck Anxiety Inventory (BAI)
Time frame: Endpoint (Week 2)
Generalized Anxiety Disorder (GAD-7) Scale
Time frame: Endpoint (Week 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40365001Rayani 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.
Related trials for Post-traumatic Stress Disorder (PTSD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Ong, MD, FRCPC principal investigator
Vancouver Coastal Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Post-traumatic Stress Disorder (PTSD), run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) (time frame: Endpoint (treatment end) (Week 2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01806168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.