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NCT06294106 Clinical Trial

eTMS for Veterans and First Responders With PTSD

Post Traumatic Stress Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06294106
Other study ID # 24-212
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 10, 2024
Est. completion date April 2026

Study information
Verified date June 2024
Source Virginia Polytechnic Institute and State University
Contact Jessica Florig, MPH
Phone 540-526-2261
Email jnw@vtc.vt.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date April 2026
Est. primary completion date April 2026
Accepts healthy volunteers No
Gender All
Age group 22 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)
EEG is utilized to determine a personalized frequency to then apply TMS to the frontal lobe.

Locations
Country Name City State
United States Fralin Biomedical Research Institute Roanoke Virginia

Sponsors (2)
Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University Wave Neuroscience

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Adverse event reports (or lack-of) will determine device safety Up to 7 weeks
Primary 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 PCL-5 Completion of the PTSD symptom questionnaire. Scores range from 0-80, with a PTSD cutoff score of 31. Up to 7 weeks
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