A Randomized Controlled Trial of Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
United States
Ohio
Wright State University
RECRUITING
Dayton
D2 Human Performance Center
RECRUITING
Pickerington
Contact Information
Primary
Matthew Sherwood, PhD
msherwood@etmsfda.com
937-775-2342
Backup
Walter Mysiw, MD
coordinator@etmsfda.com
614-293-3433
Time Frame
Start Date: 2025-02-12
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 110
Treatments
Active_comparator: Active eTMS treatment
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.
Sham_comparator: Sham eTMS Treatment
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.
Related Therapeutic Areas
Sponsors
Leads: Wave Neuroscience

This content was sourced from clinicaltrials.gov