eTMS for Veterans and First Responders With PTSD

Not Applicable

Recruiting

• Conditions: Post Traumatic Stress Disorder
• Interventions: Device: Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)

• Registration Number: NCT06294106
• Lead Sponsor: Virginia Polytechnic Institute and State University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-03-05
• Study Start: 2024-06-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-23
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Veteran or first responder
• diagnosed with post-traumatic stress disorder with PCL-5 cutoff of 31 or above

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eTMS	Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)	The active side of a TMS coil will be used to administer eTMS application.
eTMS sham	Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)	The sham side of a TMS coil will be used to administer a sham dosage of eTMS application.

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 7 weeks	Adverse event reports (or lack-of) will determine device safety
Report of Symptoms	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 Outcome Measures

Name	Time	Method
PCL-5	Up to 7 weeks	Completion of the PTSD symptom questionnaire. Scores range from 0-80, with a PTSD cutoff score of 31.
OPM	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
EEG	Up to 7 sessions collected over 7 weeks.	Electroencephalography recordings at rest and during a stress task. Specifically analyzing the P300.
fMRI	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

Trial Locations

Locations (1)

Fralin Biomedical Research Institute; 🇺🇸 Roanoke, Virginia, United States