NCT01806168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 14, 2021

Completed
Last Updated

April 14, 2021

Status Verified

March 1, 2021

Enrollment Period

6 years

First QC Date

March 4, 2013

Results QC Date

August 7, 2020

Last Update Submit

March 21, 2021

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

Post-traumatic stress disorderRepetitive transcranial magnetic stimulationCiviliansNeurostimulationDorsolateral prefrontal cortex

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (5)

  • PTSD Checklist for Civilians (PCL-C)

    Endpoint (Week 2).

  • Hamilton Depression Rating Scale, 21-item Version (HDRS-21)

    Endpoint (Week 2)

  • Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)

    Endpoint (Week 2)

  • Beck Anxiety Inventory (BAI)

    Endpoint (Week 2)

  • Generalized Anxiety Disorder (GAD-7) Scale

    Endpoint (Week 2)

Study Arms (3)

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.

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.

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.

Device: rTMS

Interventions

rTMSDEVICE

Magstim Super Rapid-2

Also known as: repetitive transcranial magnetic stimulation
High-frequency (10 Hz) rTMSLow-frequency (1 Hz) rTMSSham rTMS

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 40365001DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Limitations and Caveats

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.

Results Point of Contact

Title
Kawai Leong, MD, MSc, FRCPC
Organization
Vancouver Coastal Health / Vancouver General Hospital
kawai.leong@vch.ca
604-875-8289

Study Officials

  • Larry Ong, MD, FRCPC

    Vancouver Coastal Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 7, 2013

Study Start

September 1, 2013

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

April 14, 2021

Results First Posted

April 14, 2021

Record last verified: 2021-03

Locations

CA(1)