High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

Study Overview
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Brief Summary
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This is a double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of high-frequency (20Hz) rTMS applied to the right dorsolateral prefrontal cortex for 6 weeks. The primary objective is to evaluate the change in PTSD symptoms before and after six weeks of high-frequency rTMS treatment as measured by the Clinician Administered PTSD Scale (CAPS) in both active and control groups.

Official Title
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High Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Post-traumatic Stress Disorder (PTSD)

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Patient Information and Consent. Patients with primary Post-Traumatic Stress Disorder (as diagnosed by MINI) and DSM IV TR. Patients with CAPS score of at least 40. Males or females between 18-65 years of age. Patients not taking PTSD pharmacotherapy for at least last 2 weeks prior to commencing in the study or if they are taking PTSD pharmacotherapy it must be stable for at least 6 weeks prior to the start and not be changed during the 6 weeks of the study treatment phase. Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase. Exclusion Criteria: Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder. Other primary Axis I disorders which, in the opinion of the investigator, may affect the outcome of this study. Patients with HDRS score ≥ 18. A metallic implant in cranium (except the mouth). Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety. ECT treatment within the last three months. Patients with a history of epilepsy. Patients with neurological disorder leading to increased intracranial pressure. Patients with severe cardiac disorder or intracardiac lines and pacemakers. Patients with current suicide risk ≥ 6 points by MINI.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active rTMS<br>Repetitive Transcranial Magnetic Stimulation | Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)<br>* 6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic.<br>* Other names: rTMS machine (MagPro, Medtronic).;|
| Sham Comparator: 2<br>Device: Sham (placebo) | Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (MagPro, Medtronic)<br>* 6 weeks of either Active or Sham Repetitive Transcranial Magnetic Stimulation (rTMS). Active treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of Motor Threshold, 20 trains, 9 seconds per train, 51 seconds of intertrain interval that is applied over the Right Dorsolateral Prefrontal Cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6. Sham treatment will mimic active treatment; The rTMS machine used is MagPro and the company name is Medtronic.<br>* Other names: rTMS machine (MagPro, Medtronic).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) in both active and sham groups |  | pre, week 2,4,6,8 & 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Outcome PTSD scale (TOP-8) |  | Pre, week 2,4,6,8 & 12 | 
| Hamilton Anxiety Scale |  | Pre, week 2,4,6,8 & 12 | 
| Hamilton Depression Rating Scale |  | Pre, week 2,4,6,8 & 12 | 
| Clinical Global Impression Scale (both severity and improvement) |  | Pre, week 2,4,6,8 & 12 | 
| Social Functioning-36 Quality of Life Scale version(1) |  | Pre, week 2,4,6,8 & 12 | 
| Pittsburgh Sleep Quality Index |  | Pre, week 2,4,6,8 & 12 | 
| PTSD Checklist-civilian (PCL-C) |  | Pre, week 2,4,6,8 & 12 |