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

March 17, 2025 updated by: Wave Neuroscience

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

eTMS-PTSD-001 Stage 2 is a randomized, sham controlled study with a recruitment goal of 100 subjects, with 99 completers. The Study is intended to evaluate the safety and efficacy of eTMS in the target population. A maximum of 800 individuals will be screened in order to achieve the recruitment goal. The total number of days from the first participant enrolled to the last enrolled participant treated will be approximately 10 months.

Participants will be either Veterans or First Responders (e.g., emergency medical service provider, firefighter, or any other emergency response personnel), between 22-65 years of age. Participants may be male or female of any racial/ethnic background who meet the eligibility criteria. Participants will be recruited from the general public, and from veterans and first responder organizations.

The primary outcome for the Study will be reduction in PTSD symptoms as calculated by the PTSD Checklist for DSM-5 (PCL-5) assessment.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Dayton, Ohio, United States, 45435
        • Recruiting
        • Wright State University
        • Contact:
      • Pickerington, Ohio, United States, 45435
        • Recruiting
        • D2 Human Performance Center
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: EEG-based personalized TMS
Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG)
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.
Device: Sham Comparator
Sham Transcranial Magnetic Stimulation (TMS), in which treatment is personalized based on the participant's Electroencephalogram (EEG). No stimulation is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline and Final Measure, between 21-28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number, Severity, Relatedness, Type, Subsequent Treatment/Intervention Required, and Resolution Status of Adverse Events (AEs) During the Study.
Time Frame: Baseline and Final Measure, between 21-28 Days

Number - Number of adverse events reported. Note that each participant may have had more than one adverse event (AE).

Severity - Number of adverse events that were mild, moderate, or severe. Relatedness - Number of adverse events that were not related, suspected, or definitely related to treatment.

Type - Number of adverse events that were or were not Serious Adverse Events (SAEs).

Subsequent treatment/intervention required - Number of adverse events that did or did not require subsequent treatment/intervention.
Baseline and Final Measure, between 21-28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wave Neuroscience

Investigators

  • Principal Investigator: Bill Phillips, PhD, Wave Neuroscience, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eTMS-PTSD-001-Stage 2
  • 2021 RFP # SRC2472 DMH009 (Other Grant/Funding Number: State of Ohio)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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