TMS-fNIRS Personalized Dosing

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Adults ages 18-70 years.

• Eligible for consideration of treatment with TMS for PTSD.

• Diagnosis of PTSD based on CAPS-5.

• No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of study.

• Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study

Locations
United States
Florida
Isabelle Taylor
RECRUITING
Tallahassee
Contact Information
Primary
Isabelle Taylor, MA
fsun@med.fsu.edu
850-728-3881
Backup
Kevin Johnson, PhD, RN
fsun@med.fsu.edu
850-728-3881
Time Frame
Start Date: 2024-01-19
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Florida State University

This content was sourced from clinicaltrials.gov