EEG Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder

Not Applicable

Completed

Brief Summary: This is an open-label safety pilot study of the Electroencephalogram (EEG) Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 30 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 10 in-office visits that take place over 21 total days. Two eTMS treatment sessions are administered during each office visit.

Detailed Description: eTMS-PTSD-001 is an open-label safety pilot study with a recruitment goal of 30 subjects, with 26 completers. The Study is intended to evaluate the safety aspects of eTMS in the target population. A maximum of 400 individuals will be screened in order to achieve the recruitment goal. The total number of days from the first participant enrolled to the last enrolled participant treated will be approximately 7 months.

Participants will be either Veterans or First Responders (e.g., emergency medical service provider, firefighter, or any other emergency response personnel), between 22-65 years of age. Participants may be male or female of any racial/ethnic background who meet the eligibility criteria. Participants will be recruited from the general public, and from veterans and first responder organizations.

The primary outcome for the Study will be the incidence, severity, relatedness, type, subsequent treatment/intervention required, and resolution status of adverse events during the study.

Recruitment & Eligibility

Inclusion Criteria

Willing and able to consent to participate in the study via signed Informed Consent
Age 22 - 65 years
Provisional diagnosis of PTSD
Positive identification as either a Veteran, or First Responder (e.g., emergency medical service provider, firefighter, or any other emergency response personnel)

Exclusion Criteria

Uncontrolled medical, psychological or neurological condition
Pregnant, or female unwilling to use effective birth control during the course of the trial
Metal objects implanted in the head
Past exposure to metal fragments or other metal sources in the head and neck
Current participation in any interventional research protocol
History of any type of Electroconvulsive Therapy (ECT) or TMS
History of stroke or intracranial lesion, or increased intracranial pressure
History or epilepsy or seizure
Family history of epilepsy or seizure in 1st degree relative.

Primary Outcome Measures

Name	Time	Method
Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.	Baseline and Final Measure, between 10-21 Days	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. Number of participants reporting at least one AE

Secondary Outcome Measures

Name	Time	Method
Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5)	Baseline and Final Measure, between 10-21 Days	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.