eTMS for Veterans and First Responders With PTSD

Virginia Polytechnic Institute and State University

Status: Enrolling

Conditions: Post Traumatic Stress Disorder

Treatments: Device: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06294106

24-212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

eTMS

Experimental group

Description:

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

Treatment:

Device: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

eTMS sham

Sham Comparator group

Description:

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

Treatment:

Device: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)