The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder

Study Overview
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Brief Summary
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The purpose of this trial is to study the effect of noninvasive brain stimulation in adults with post-traumatic stress disorder.

Detailed Description
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The purpose of this trial is to study the effect of noninvasive brain stimulation on symptoms severity in adults with post-traumatic stress disorder.

Official Title
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The Use of Noninvasive Brain Stimulation in Post-traumatic Stress Disorder

Conditions
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Post-traumatic Stress Disorder

Intervention / Treatment
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* Device: Active repetitive Transcranial Magnetic Stimulation
* Device: Sham repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-60 years old Exclusion Criteria: Transcranial magnetic stimulation ineligibility

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active transcranial magnetic stimulation<br>Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device. | Device: Active repetitive Transcranial Magnetic Stimulation<br>* Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.<br>|
| Sham Comparator: Sham transcranial magnetic stimulation<br>Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device. | Device: Sham repetitive Transcranial Magnetic Stimulation<br>* Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of symptoms on the following clinical scale: PTSD symptoms as assessed by the Modified PTSD Symptom Scale (MPSS-SR) | Units will be the differences (%) in scores before and after the intervention | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of symptoms on the following clinical scale: anxiety symptoms as assessed by the Beck Anxiety Inventory (BAI) | Units will be the differences (%) in scores before and after the intervention | 2 months | 
| Severity of symptoms on the following clinical scale: depression symptoms as assessed by the Beck Depression Inventory (BDI) | Units will be the differences (%) in scores before and after the intervention | 2 months |