TMS-fNIRS Personalized Dosing

Last updated: February 25, 2025
Sponsor: Florida State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Traumatic Brain Injury

Post-traumatic Stress Disorders

Neurologic Disorders

Treatment

TMS-fNIRS over the dl-PFC

Clinical Study ID

NCT05916417
STUDY00004007
CDMRP-TP220192
  • Ages 18-70
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria

  1. Adults ages 18-70 years.

  2. Eligible for consideration of treatment with TMS for PTSD.

  3. Diagnosis of PTSD based on CAPS-5.

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

  5. Clinically competent to give informed written consent and ability to understandstudy procedures and to comply with them for the entire length of the study

Exclusion

Exclusion Criteria:

  1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizuredisorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).

  2. Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate).

  3. Active substance use disorder in last 3 months or any current substance use thatputs the participant at increased risk or significant impairment

  4. Dementia or other cognitive disorder making unable to engage in study.

  5. Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, DelusionalDisorder or other psychotic illness.

  6. Suicidal risk that precludes safe participation defined as clinical impression thatthe participant is at significant risk for suicide.

  7. OCD cannot be the primary disorder but can have OCD symptoms

  8. Taking any medication that significantly lowers the seizure threshold (e.g.,tricyclic antidepressants, clozapine, etc.)

  9. Current, planned, or suspected pregnancy

  10. Unstable medical conditions or any current medical condition that could precludebeing able to safely participate in TMS treatment (e.g., unstable metabolicabnormality, unstable angina, etc.)

  11. Severe Traumatic Brain Injury

  12. Prior TMS treatment or already received TMS as part of a study.

  13. Significant ongoing litigation or claims that impact research activities, asdetermined by the research study team. (Research may especially be impacted whenmental health or pain is being evaluated for litigation or claims, such as civil andcriminal cases, disability claims and worker's compensation).

We will exclude non-English speakers because of the need for rapid communication during the testing.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: TMS-fNIRS over the dl-PFC
Phase:
Study Start date:
January 19, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Isabelle Taylor

    Tallahassee, Florida 32306
    United States

    Active - Recruiting

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