rTMS in the Treatment of PTSD

Not Applicable

Completed

• Conditions: Post-traumatic Stress Disorder (PTSD)
• Interventions: Device: rTMS

• Registration Number: NCT01806168
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-04
• Study First Submitted QC: 2013-03-05
• Study First Posted: 2013-03-07
• Study Start: 2013-09
• Primary Completion: 2019-09
• Study Completion: 2019-10
• Results First Submitted: 2020-08-07
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-21
• Last Update Submitted: 2021-03-21
• Results First Posted: 2021-04-14
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham rTMS	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.
Low-frequency (1 Hz) rTMS	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.
High-frequency (10 Hz) rTMS	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.

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)	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).

Secondary Outcome Measures

Name	Time	Method
PTSD Checklist for Civilians (PCL-C)	Endpoint (Week 2).	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".
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)	Endpoint (Week 2)	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.
Hamilton Depression Rating Scale, 21-item Version (HDRS-21)	Endpoint (Week 2)	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).
Beck Anxiety Inventory (BAI)	Endpoint (Week 2)	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.
Generalized Anxiety Disorder (GAD-7) Scale	Endpoint (Week 2)	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.

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada