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TMS-fNIRS Personalized Dosing

Primary Purpose

Post Traumatic Stress Disorder, Traumatic Brain Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TMS-fNIRS over the dl-PFC
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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 Exclusion Criteria: Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.). Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate). Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment Dementia or other cognitive disorder making unable to engage in study. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide. OCD cannot be the primary disorder but can have OCD symptoms Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.) Current, planned, or suspected pregnancy Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.) Severe Traumatic Brain Injury Prior TMS treatment or already received TMS as part of a study. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation). We will exclude non-English speakers because of the need for rapid communication during the testing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    TMS-fNIRS over the dl-PFC (Active)

    TMS-fNIRS over the dl-PFC (Sham)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 15, 2023
    Last Updated
    June 22, 2023
    Sponsor
    Florida State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05916417
    Brief Title
    TMS-fNIRS Personalized Dosing
    Official Title
    TMS-fNIRS Personalized Dosing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    August 1, 2025 (Anticipated)
    Study Completion Date
    October 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Florida State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Traumatic Stress Disorder, Traumatic Brain Injury

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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).
    Masking
    ParticipantInvestigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TMS-fNIRS over the dl-PFC (Active)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    TMS-fNIRS over the dl-PFC (Sham)
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    TMS-fNIRS over the dl-PFC
    Intervention Description
    Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light.
    Primary Outcome Measure Information:
    Title
    TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)
    Description
    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.
    Time Frame
    Months 3-36

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria 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 Exclusion Criteria: Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.). Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate). Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment Dementia or other cognitive disorder making unable to engage in study. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness. Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide. OCD cannot be the primary disorder but can have OCD symptoms Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.) Current, planned, or suspected pregnancy Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.) Severe Traumatic Brain Injury Prior TMS treatment or already received TMS as part of a study. Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation). We will exclude non-English speakers because of the need for rapid communication during the testing.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Isabelle Taylor, MA
    Phone
    850-728-3881
    Email
    fsun@med.fsu.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kevin Johnson, PhD, RN
    Phone
    850-728-3881
    Email
    fsun@med.fsu.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A.
    Organizational Affiliation
    Florida State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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