This is a randomized, sham controlled study of the Electroencephalogram (EEG) based Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 110 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 15 in-office visits that take place over 21-28 total days. Two eTMS treatment sessions are administered during each office visit.
Willing and able to consent to participate in the study via signed Informed Consent
Age 22 - 65 years
Diagnosis of PTSD according to DSM-5 criteria via the Clinician-Administered PTSD Scale (CAPS).
Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms persisting for a minimum of 6 months prior to the Screening Visit
Uncontrolled medical, psychological or neurological condition
Pregnant, or female unwilling to use effective birth control during the course of the trial
Metal objects in the head
Past exposure to metal fragments, permanent piercings, and/or other possible metal sources in the head and neck
Parallel
EEG-based personalized TMS
DeviceTranscranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
Sham Comparator
DeviceSham Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG). No stimulation is provided.
Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)
The Post Traumatic Stress Disorder (PTSD) Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5), commonly referred to as PCL-5, is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. It is used to monitor symptom change during and after treatment. Each item is scored from 0 to 5 as the participant's estimate of the severity of the symptom (0 = Not at all, 1=A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). The final score range is between 0-80. A lower score is considered better than a higher score.
Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Number - Number of adverse events reported. Note that each participant may have had more than one adverse event (AE). Severity - Number of adverse events that were mild, moderate, or severe. Relatedness - Number of adverse events that were not related, suspected, or definitely related to treatment. Type - Number of adverse events that were or were not Serious Adverse Events (SAEs). Subsequent treatment/intervention required - Number of adverse events that did or did not require subsequent treatment/intervention.
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