| NCT ID | NCT05916417 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida State University |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-01-19 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
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/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of study. 5. 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: 1. Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, 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 that puts 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, Delusional Disorder or other psychotic illness. 6. Suicidal risk that precludes safe participation defined as clinical impression that the 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 preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, 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, 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.
Contact & Investigator
Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A.
PRINCIPAL INVESTIGATOR
Florida State University
Frequently Asked Questions
Who can join the NCT05916417 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05916417 currently recruiting?
Yes, NCT05916417 is actively recruiting participants. Contact the research team at fsun@med.fsu.edu for enrollment information.
Where is the NCT05916417 trial being conducted?
This trial is being conducted at Tallahassee, United States.
Who is sponsoring the NCT05916417 clinical trial?
NCT05916417 is sponsored by Florida State University. The principal investigator is Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A. at Florida State University. The trial plans to enroll 60 participants.