Personalized brain stimulation treatment for PTSD in veterans and first responders
A Randomized Controlled Trial of Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder
This study is testing a personalized brain stimulation treatment to see if it can help veterans and first responders with PTSD feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 22 Years to 65 Years |
| Sex | All |
| Sponsor | Wave Neuroscience Industry-sponsored |
| Locations | 2 sites (Dayton, Ohio and 1 other locations) |
| Trial ID | NCT06892028 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of EEG-based Transcranial Magnetic Stimulation (eTMS) in treating Post-Traumatic Stress Disorder (PTSD) among U.S. military veterans and first responders. Participants will undergo EEG recordings to tailor the eTMS treatment, followed by 15 in-office sessions over 21-28 days. The study aims to recruit 110 individuals and will assess the reduction of PTSD symptoms using the PTSD Checklist for DSM-5 (PCL-5). It is a randomized, sham-controlled trial designed to ensure the reliability of results.
Who should consider this trial
Good fit: Ideal candidates are U.S. military veterans or first responders aged 22-65 with a diagnosis of PTSD persisting for at least 6 months.
Not a fit: Patients with uncontrolled medical or psychological conditions, or those with metal objects in their head, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce PTSD symptoms in veterans and first responders, improving their quality of life.
How similar studies have performed: Previous studies using TMS for PTSD have shown promise, indicating potential for success with this novel EEG-based approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Dayton, Ohio and 1 other locations
- Wright State University — Dayton, Ohio, United States (Recruiting)
- D2 Human Performance Center — Pickerington, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Bill Phillips, PhD — Wave Neuroscience, Inc.
- Study coordinator: Matthew Sherwood, PhD
- Email: msherwood@etmsfda.com
- Phone: 937-775-2342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.