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| ID | Type | Description | Link |
|---|---|---|---|
| 2021 RFP # SRC2472 DMH009 | Other Grant/Funding Number | State of Ohio |
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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.
eTMS-PTSD-001 Stage 2 is a randomized, sham controlled study with a recruitment goal of 100 subjects, with 99 completers. The Study is intended to evaluate the safety and efficacy of eTMS in the target population. A maximum of 800 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 10 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 reduction in PTSD symptoms as calculated by the PTSD Checklist for DSM-5 (PCL-5) assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active eTMS treatment | Active Comparator | 15 treatment days of EEG-based personalized TMS over a maximum of 28 days. Two sessions per treatment day. Each session consists of TMS treatment at 80% 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. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day. |
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| Sham eTMS Treatment | Sham Comparator | 15 treatment days of sham EEG-based personalized TMS over a maximum of 28 days. Two sessions per treatment day. Each session consists of sham TMS treatment. TMS delivery of 5 second pulse train, with an inter-train interval of 20 seconds. Session duration is 15 minutes. A rest period of at least 30 minutes is required between the 2 sessions in a treatment day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG-based personalized TMS | Device | Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Final Measure, between 21-28 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Sherwood, PhD | Contact | 937-775-2342 | msherwood@etmsfda.com | |
| Walter Mysiw, MD | Contact | 614-293-3433 | coordinator@etmsfda.com |
| Name | Affiliation | Role |
|---|---|---|
| Bill Phillips, PhD | Wave Neuroscience, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wright State University | Recruiting | Dayton | Ohio | 45435 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17493877 | Background | Bae EH, Schrader LM, Machii K, Alonso-Alonso M, Riviello JJ Jr, Pascual-Leone A, Rotenberg A. Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. Epilepsy Behav. 2007 Jun;10(4):521-8. doi: 10.1016/j.yebeh.2007.03.004. Epub 2007 May 9. | |
| 17636720 | Background |
| Label | URL |
|---|---|
| Study Information Page | View source |
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Individual Participant Data will not be shared with other researchers
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Sham Comparator | Device | Sham Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG). No stimulation is provided. |
|
| Baseline and Final Measure, between 21-28 Days |
| D2 Human Performance Center | Recruiting | Pickerington | Ohio | 45435 | United States |
|
| Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2007 Jul 18;(3):CD003388. doi: 10.1002/14651858.CD003388.pub3. |
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