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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-TP220192 | Other Grant/Funding Number | Department of Defense |
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The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS.
Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS-fNIRS over the dl-PFC (Active) | Active Comparator | TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols. |
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| TMS-fNIRS over the dl-PFC (Sham) | Sham Comparator | TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS-fNIRS over the dl-PFC | Device | Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light. |
| Measure | Description | Time Frame |
|---|---|---|
| TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC) | The magnitude of brain activation based on fNIRS signal for the respective cortices at the individual level will be assessed and compared for the MC and dl-PFC. | Months 3-33 |
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Inclusion Criteria
Exclusion Criteria:
We will exclude non-English speakers because of the need for rapid communication during the testing.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle Taylor, MA | Contact | 850-728-3881 | fsun@med.fsu.edu | |
| Kevin Johnson, PhD, RN | Contact | 850-728-3881 | fsun@med.fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A. | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isabelle Taylor | Recruiting | Tallahassee | Florida | 32306 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 10, 2023 | Jun 22, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001930 | Brain Injuries |
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A total of 60 participants will be recruited and assigned to one of the two arms (active or sham TMS) at a 4:1 ratio (i.e., 48 participants for the active TMS group and 12 for the sham group).
The primary outcome is the MC or dl-PFC fNIRS signal, and a total of 12 comparisons will be conducted (i.e., one test for Aim 1; one for Aim 2; and 10 for Aim 3, considering the comparisons of CNR and TDR for the four longer paradigms as well as the shorter paradigm).
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Blinding Procedures The participants, PI, Research Staff involved in TMS treatment, and staff performing the study procedures will be blinded to the participant's dl-PFC protocol assignment throughout the study.
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |