Clinical trial NCT05916417: TMS-fNIRS Personalized Dosing
Official title: TMS-fNIRS Personalized Dosing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Traumatic Brain Injury
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: OTHER

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.

Primary outcomes:
measure: TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)
timeFrame: Months 3-33
Secondary outcomes:
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Isabelle Taylor
state: Florida
Study officials:
affiliation: Florida State University
name: Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A.
role: PRINCIPAL_INVESTIGATOR
References: