Clinical trial NCT01806168: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder (PTSD)
Keywords: Post-traumatic stress disorder
Repetitive transcranial magnetic stimulation
Civilians
Neurostimulation
Dorsolateral prefrontal cortex
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Coastal Health
First posted: 2013-03-07
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)
timeFrame: Endpoint (treatment end) (Week 2).
Secondary outcomes:
measure: PTSD Checklist for Civilians (PCL-C)
timeFrame: Endpoint (Week 2).
measure: Hamilton Depression Rating Scale, 21-item Version (HDRS-21)
timeFrame: Endpoint (Week 2)
measure: Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
timeFrame: Endpoint (Week 2)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Endpoint (Week 2)
measure: Generalized Anxiety Disorder (GAD-7) Scale
timeFrame: Endpoint (Week 2)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: Vancouver Coastal Health
name: Larry Ong, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: