eTMS for Veterans and First Responders With PTSD

Electroencephalogram (EEG) Personalized Transcranial Magnetic Stimulation (eTMS) for Post-Traumatic Stress Disorder (PTSD)

A battery of physiological and behavioral data will be collected before and after application of eTMS. Participants will be veterans or first responders diagnosed with PTSD. Study will be a double-blind, sham-controlled, parallel group, randomized clinical trial.

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Device: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

Detailed Description

Veterans and first responders diagnosed with PTSD will be studied to evaluate safety and efficacy of an EEG personalized TMS paradigm. All participants will undergo 2 days of extensive testing prior to eTMS application and 2 days of testing after. Testing will include MRI, OPM, EEG, behavioral tasks, questionnaires, and an EEG sleep study.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Florig, MPH; Phone Number: 540-526-2261; Email: jnw@vtc.vt.edu

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Recruiting
      • Fralin Biomedical Research Institute
      • Principal Investigator: Wynn Legon, PhD
      • Contact: Jessica Florig, MPH; Phone Number: 540-526-2261; Email: jnw@vtc.vt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Veteran or first responder
• diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above

Exclusion Criteria:

• Claustrophobia
• Contraindications to MRI
• Pregnant
• Uncontrolled medical, psychological, or neurological conditions
• Unable to calculate EEG alpha frequency
• History of ECT or rTMS
• History of intracranial lesion or increased intracranial pressure
• History of stroke
• History of other neurologic conditions
• Family history of epilepsy
• Personal history of epilepsy
• certain medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eTMS; The active side of a TMS coil will be used to administer eTMS application.	Device: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS); EEG is utilized to determine a personalized frequency to then apply TMS to the frontal lobe.
Sham Comparator: eTMS sham; The sham side of a TMS coil will be used to administer a sham dosage of eTMS application.	Device: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS); EEG is utilized to determine a personalized frequency to then apply TMS to the frontal lobe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Adverse event reports (or lack-of) will determine device safety	Up to 7 weeks
Report of Symptoms	Symptom questionnaire to be completed before and after all study procedures to determine feasibility in this patient population. Various symptoms will be rated on a likert scale from absent to severe.	Up to 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCL-5	Completion of the PTSD symptom questionnaire. Scores range from 0-80, with a PTSD cutoff score of 31.	Up to 7 weeks
fMRI	Functional MRI signals including BOLD signals collected at rest and during basic tasks to assess neuropathways of activation	1 session 1 week pre treatment and 1 session 1 week post treatment
OPM	Optically Pumped Magnetometry signals collected at rest and during basic tasks to assess neuropathways of activation	1 session 1 week pre treatment and 1 session 1 week post treatment
EEG	Electroencephalography recordings at rest and during a stress task. Specifically analyzing the P300.	Up to 7 sessions collected over 7 weeks.

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: Wave Neuroscience
• Investigators: Principal Investigator: Wynn Legon, PhD, Virginia Polytechnic Institute and State University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 24-212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No