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

Study Overview
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Brief Summary
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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 20 in-office treatments over 35 days.

Detailed Description
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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.

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

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Device: EEG-based personalized TMS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 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
Intervention Model: Single Group Assignment
Interventional Model Description: This is an open-label safety pilot study of EEG-based personalized TMS
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label active EEG-based personalized TMS treatment<br>20 sessions of EEG-based personalized TMS over a maximum of 35 days. One session maximum per day. Each session consists of TMS treatment at 50% Motor Threshold, pulse frequency between 8-13 Hz. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. | Device: EEG-based personalized TMS<br>* Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Safety | Incidence, severity, relatedness, type, subsequent treatment/intervention required, and resolution status of adverse events during the study | Assessed at all treatment sessions and Follow-up Visit, a duration of up to 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Veterans, First Responders