Post Traumatic Stress Disorder
Conditions
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.
Interventions
DEVICEElectroencephalogram personalized Transcranial Magnetic Stimulation (eTMS)
EEG is utilized to determine a personalized frequency to then apply TMS to the frontal lobe.
Sponsors
Virginia Polytechnic Institute and State University
Wave Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
10 participants will receive eTMS treatment 10 participants will receive sham eTMS treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| PCL-5 | Up to 7 weeks | Completion of the PTSD symptom questionnaire. Scores range from 0-80, with a PTSD cutoff score of 31. |
| 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 |
| 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. |
Countries
United States
Contacts
CONTACTJessica Florig, MPH
PRINCIPAL_INVESTIGATORWynn Legon, PhD
Virginia Polytechnic Institute and State University
Outcome results
None listed