Post-traumatic Stress Disorder (PTSD) Clinical Trial
Official title:
The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder
Verified date | March 2021 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | October 2019 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Vancouver Coastal Health |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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). | Endpoint (treatment end) (Week 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". | 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). | 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. | 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. | 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. | Endpoint (Week 2) |
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