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Clinical Trials in the USA / NCT06892028
Recruiting Not applicable

EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) to Treat Post-Traumatic Stress Disorder

NCT06892028 · tracked via the Priya Life Science USA tracker
Sponsor
Wave Neuroscience
Phase
Not applicable
Started
2025-02-12
Last updated
2025-03-24

Condition(s) studied

Stress Disorder, Post Traumatic

Investigational drug(s) / intervention(s)

EEG-based personalized TMSSham Comparator

EEG-based personalized TMS: Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)

Sham Comparator: Sham Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG). No stimulation is provided.

Study 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 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5) — Baseline and Final Measure, between 21-28 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.

Trial sites (2)

FacilityCityRegionStatus
Wright State University Dayton Ohio Recruiting
D2 Human Performance Center Pickerington Ohio Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06892028 on ClinicalTrials.gov ↗ ← All trials in the USA