Recruiting

eTMS

Sponsor:

Wave Neuroscience

Code:

NCT06892028

Conditions

Stress Disorder, Post Traumatic

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

Interventions

EEG-based personalized TMS

Sham Comparator

Study Details

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 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.

Conditions

Stress Disorder, Post Traumatic

Study ID

NCT06892028

Start date

Feb 12, 2025

Status verified date

Mar, 2025

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Improvement in PTSD Symptoms as Measured by Drop in Score on the PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline and Final Measure, between 21-28 Days ]

Central Contacts and Locations

Central contacts

Matthew Sherwood, PhD

937-775-2342msherwood@etmsfda.com

Walter Mysiw, MD

614-293-3433coordinator@etmsfda.com

Locations

Wright State University

Recruiting

Dayton, Ohio, United States, 45435

Contacts

Matt Sherwood, PhD

937-524-3924matt.sherwood@wright.edu

D2 Human Performance Center

Recruiting

Pickerington, Ohio, United States, 45435

Contacts

Erin Woodburn

937-775-2342coordinator@etmsfda.com

More Information

Sponsor

Wave Neuroscience

Last update posted

Mar 24, 2025

Last verified

Mar, 2025

Keywords

  • PTSD
  • Veterans
  • First Responders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wave Neuroscience on 2025-03-24.