TMS-fNIRS Personalized Dosing

Part of paid clinical trials in Tallahassee, Florida.

Sponsor
Florida State University
Study ID
NCT05916417
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Isabelle TaylorTallahasseeFlorida32306
Isabelle M Taylor, MA
850-728-3881
Kevin Johnson, PhD
850-728-3881

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