eTMS for Veterans and First Responders With PTSD

NCT ID: NCT06294106

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-10

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

10 participants will receive eTMS treatment 10 participants will receive sham eTMS treatment
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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eTMS

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

Group Type EXPERIMENTAL

Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

Intervention Type DEVICE

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

eTMS sham

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

Group Type SHAM_COMPARATOR

Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

Intervention Type DEVICE

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

Interventions

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Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wave Neuroscience

INDUSTRY

Sponsor Role collaborator

Virginia Polytechnic Institute and State University

OTHER

Sponsor Role lead

Responsible Party

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Wynn Legon

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wynn Legon, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

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Fralin Biomedical Research Institute

Roanoke, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Florig, MPH

Role: CONTACT

540-526-2261

Facility Contacts

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Jessica Florig, MPH

Role: primary

540-526-2261

Other Identifiers

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24-212

Identifier Type: -

Identifier Source: org_study_id

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