Status:
RECRUITING
EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) to Treat Post-Traumatic Stress Disorder
Lead Sponsor:
Wave Neuroscience
Conditions:
Stress Disorder, Post Traumatic
Eligibility:
All Genders
22-65 years
Phase:
NA
Brief Summary
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 i...
Detailed Description
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 targe...
Eligibility Criteria
Inclusion
- 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
- Veterans Administration PCL-5 cut point score of 31 or above
- Positive identification as either a Veteran, or First Responder (e.g., emergency medical service provider, firefighter, or any other emergency response personnel)
Exclusion
- 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
- Current participation in any interventional research protocol
- History of any type of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
- History of stroke or intracranial lesion or increased intracranial pressure
- History of epilepsy of seizure
- Family history of epilepsy or seizure in 1st degree relative
- An elevated risk of suicide or violence to others
Key Trial Info
Start Date :
February 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06892028
Start Date
February 12 2025
End Date
January 31 2026
Last Update
March 24 2025
Active Locations (2)
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1
Wright State University
Dayton, Ohio, United States, 45435
2
D2 Human Performance Center
Pickerington, Ohio, United States, 45435