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NCT Number: NCT05916417

TMS-fNIRS Personalized Dosing

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)

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle Taylor, MA

CONTACT

[email protected]

850-728-3881

Kevin Johnson, PhD, RN

CONTACT

[email protected]

850-728-3881

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 23, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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