rTMS in the Treatment of PTSD

NCT ID: NCT01806168

Last Updated: 2021-04-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-traumatic Stress Disorder (PTSD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

Magstim Super Rapid-2

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.

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

Magstim Super Rapid-2

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.

Group Type PLACEBO_COMPARATOR

rTMS

Intervention Type DEVICE

Magstim Super Rapid-2

Interventions

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rTMS

Magstim Super Rapid-2

Intervention Type DEVICE

Other Intervention Names

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repetitive transcranial magnetic stimulation

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vancouver Coastal Health

OTHER_GOV

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Peter Y Chan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Larry Ong, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Vancouver Coastal Health

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 40365001 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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V12-01578

Identifier Type: OTHER

Identifier Source: secondary_id

H12-01578

Identifier Type: -

Identifier Source: org_study_id

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