eTMS for Veterans and First Responders With PTSD

NCT06294106 | Recruiting FDA Device

• 1 other identifier: 24-212
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• PCL-5

  Up to 7 weeks

• fMRI

  1 session 1 week pre treatment and 1 session 1 week post treatment

• OPM

  1 session 1 week pre treatment and 1 session 1 week post treatment

• EEG

  Up to 7 sessions collected over 7 weeks.

Study Arms (2)

eTMS

EXPERIMENTAL

The active side of a TMS coil will be used to administer eTMS application.

Device: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

eTMS sham

SHAM COMPARATOR

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)

Interventions

Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS) DEVICE

EEG is utilized to determine a personalized frequency to then apply TMS to the frontal lobe.

eTMS; eTMS sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• Wave Neuroscience: collaborator

Study Sites (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Wynn Legon, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Florig, MPH

CONTACT

540-526-2261; jnw@vtc.vt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: eTMS coil will have an 'active' and 'sham' side and the application will look identical to the participant. The technician will not know which side of the coil is which and will additionally be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 10 participants will receive eTMS treatment 10 participants will receive sham eTMS treatment

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 5, 2024
• Study Start: June 10, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)