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NCT Number: NCT06294106

eTMS for Veterans and First Responders With 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.

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Key information

Conditions

Post Traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fralin Biomedical Research Institute

Roanoke, Virginia, 24016, United States

Location status: Recruiting

Location contact

Jessica Florig, MPH

CONTACT

[email protected]

540-526-2261

Wynn Legon, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

Device

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

Primary outcomes

  1. Adverse Events

    Time frame: Up to 7 weeks

    Adverse event reports (or lack-of) will determine device safety

  2. Report of Symptoms

    Time frame: Up to 7 weeks

    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.

Secondary outcomes

  1. PCL-5

    Time frame: Up to 7 weeks

    Completion of the PTSD symptom questionnaire. Scores range from 0-80, with a PTSD cutoff score of 31.

  2. fMRI

    Time frame: 1 session 1 week pre treatment and 1 session 1 week post treatment

    Functional MRI signals including BOLD signals collected at rest and during basic tasks to assess neuropathways of activation

  3. OPM

    Time frame: 1 session 1 week pre treatment and 1 session 1 week post treatment

    Optically Pumped Magnetometry signals collected at rest and during basic tasks to assess neuropathways of activation

  4. EEG

    Time frame: Up to 7 sessions collected over 7 weeks.

    Electroencephalography recordings at rest and during a stress task. Specifically analyzing the P300.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Florig, MPH

CONTACT

[email protected]

540-526-2261

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Collaborators

  • Wave Neuroscience

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2024
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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