Personalized TMS-fNIRS treatment for PTSD and TBI
TMS-fNIRS Personalized Dosing
This study is testing a new way to use brain stimulation and monitoring to see if it can improve treatment for people with PTSD and mild brain injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Florida State University Academic / other |
| Locations | 1 site (Tallahassee, Florida) |
| Trial ID | NCT05916417 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of using personalized transcranial magnetic stimulation combined with functional near-infrared spectroscopy (TMS-fNIRS) to measure frontal brain activity in patients with post-traumatic stress disorder (PTSD) and mild traumatic brain injury (TBI). The approach seeks to improve the dosing accuracy of TMS therapy by replacing traditional methods that may lead to improper treatment levels. Participants will undergo TMS-fNIRS to guide their therapy, potentially enhancing treatment outcomes for depression, PTSD, and TBI.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of PTSD who are eligible for TMS treatment.
Not a fit: Patients with medical contraindications for neuromodulation or those unable to undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatments for patients suffering from PTSD and TBI.
How similar studies have performed: While the specific combination of TMS and fNIRS is novel, similar studies using TMS for PTSD have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tallahassee, Florida
- Isabelle Taylor — Tallahassee, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A. — Florida State University
- Study coordinator: Isabelle Taylor, MA
- Email: fsun@med.fsu.edu
- Phone: 850-728-3881
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.