eTMS for Veterans and First Responders With PTSD

Virginia Polytechnic Institute and State University20 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Post Traumatic Stress Disorder

Interventions

Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)DEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Fralin Biomedical Research Institute

Roanoke, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Adverse Events

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

Time frame: 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.

Time frame: Up to 7 weeks

Secondary Outcomes

PCL-5

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

Time frame: Up to 7 weeks

fMRI

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

Time frame: 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

Time frame: 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.

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

Central Contacts

Jessica Florig, MPH

CONTACT

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

Data from ClinicalTrials.gov

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