RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-12
Study Completion:2026-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06892028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to consent to participate in the study via signed Informed Consent
  2. * Age 22 - 65 years
  3. * Diagnosis of PTSD according to DSM-5 criteria via the Clinician-Administered PTSD Scale (CAPS).
  4. * Onset of symptoms meeting the DSM-5 criteria for PTSD symptoms persisting for a minimum of 6 months prior to the Screening Visit
  5. * Veterans Administration PCL-5 cut point score of 31 or above
  6. * Positive identification as either a Veteran, or First Responder (e.g., emergency medical service provider, firefighter, or any other emergency response personnel)
  1. * Uncontrolled medical, psychological or neurological condition
  2. * Pregnant, or female unwilling to use effective birth control during the course of the trial
  3. * Metal objects in the head
  4. * Past exposure to metal fragments, permanent piercings, and/or other possible metal sources in the head and neck
  5. * Current participation in any interventional research protocol
  6. * History of any type of Electroconvulsive Therapy (ECT) or repetitive Transcranial Magnetic Stimulation (rTMS)
  7. * History of stroke or intracranial lesion or increased intracranial pressure
  8. * History of epilepsy of seizure
  9. * Family history of epilepsy or seizure in 1st degree relative
  10. * An elevated risk of suicide or violence to others

Contacts and Locations

Study Contact

Matthew Sherwood, PhD
CONTACT
937-775-2342
msherwood@etmsfda.com
Walter Mysiw, MD
CONTACT
614-293-3433
coordinator@etmsfda.com

Principal Investigator

Bill Phillips, PhD
PRINCIPAL_INVESTIGATOR
Wave Neuroscience, Inc.

Study Locations (Sites)

Wright State University
Dayton, Ohio, 45435
United States
D2 Human Performance Center
Pickerington, Ohio, 45435
United States

Collaborators and Investigators

Sponsor: Wave Neuroscience

  • Bill Phillips, PhD, PRINCIPAL_INVESTIGATOR, Wave Neuroscience, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-12
Study Completion Date2026-01-31

Study Record Updates

Study Start Date2025-02-12
Study Completion Date2026-01-31

Terms related to this study

Keywords Provided by Researchers

  • PTSD
  • Veterans
  • First Responders

Additional Relevant MeSH Terms

  • Stress Disorder, Post Traumatic