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| Name | Class |
|---|---|
| Wave Neuroscience | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eTMS | Experimental | The active side of a TMS coil will be used to administer eTMS application. |
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| eTMS sham | Sham Comparator | The sham side of a TMS coil will be used to administer a sham dosage of eTMS application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroencephalogram personalized Transcranial Magnetic Stimulation (eTMS) | Device | EEG is utilized to determine a personalized frequency to then apply TMS to the frontal lobe. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse event reports (or lack-of) will determine device safety | 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. | Up to 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PCL-5 | Completion of the PTSD symptom questionnaire. Scores range from 0-80, with a PTSD cutoff score of 31. | Up to 7 weeks |
| fMRI | Functional MRI signals including BOLD signals collected at rest and during basic tasks to assess neuropathways of activation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Florig, MPH | Contact | 540-526-2261 | jnw@vtc.vt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Wynn Legon, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute | Recruiting | Roanoke | Virginia | 24016 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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10 participants will receive eTMS treatment 10 participants will receive sham eTMS treatment
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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.
| 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 | 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. | Up to 7 sessions collected over 7 weeks. |