rTMS in the Treatment of PTSD

Study Overview
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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.

Official Title
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The Role of Fast or Slow Repetitive Transcranial Magnetic Stimulation as Adjunct Therapy in Civilian Post-Traumatic Stress Disorder

Conditions
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Post-traumatic Stress Disorder (PTSD)

Intervention / Treatment
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* Device: rTMS


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-frequency (1 Hz) rTMS<br>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<br>* Magstim Super Rapid-2<br>* Other names: repetitive transcranial magnetic stimulation;|
| Active Comparator: High-frequency (10 Hz) rTMS<br>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<br>* Magstim Super Rapid-2<br>* Other names: repetitive transcranial magnetic stimulation;|
| Placebo Comparator: Sham rTMS<br>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<br>* Magstim Super Rapid-2<br>* Other names: repetitive transcranial magnetic stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-traumatic stress disorder, Repetitive transcranial magnetic stimulation, Civilians, Neurostimulation, Dorsolateral prefrontal cortex