TMS-fNIRS Personalized Dosing
Part of paid clinical trials in Tallahassee, Florida.
- Sponsor
- Florida State University
- Study ID
- NCT05916417
- Status
- Recruiting
Conditions
- Post Traumatic Stress Disorder
- Traumatic Brain Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- TMS-fNIRS over the dl-PFC — DEVICETranscranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light.
Study Details
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)
Key Dates
- Start date
- Jan 19, 2024
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Active Comparator: TMS-fNIRS over the dl-PFC (Active)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.
- Sham Comparator: TMS-fNIRS over the dl-PFC (Sham)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.
Primary Outcome Measure
TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC) [ Time Frame: Months 3-33 ]
Central Contacts
- Isabelle Taylor, MA850-728-3881
- Kevin Johnson, PhD, RN850-728-3881
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Isabelle Taylor | Tallahassee | Florida | 32306 |
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