TMS-fNIRS Personalized Dosing

Florida State University

Status: Enrolling

Conditions: Traumatic Brain Injury; Post Traumatic Stress Disorder

Treatments: Device: TMS-fNIRS over the dl-PFC

Study type: Interventional

Funder types: Other

Identifiers

NCT05916417

STUDY00004007

CDMRP-TP220192 (Other Grant/Funding Number)

Details and patient eligibility

About

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)

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

TMS-fNIRS over the dl-PFC (Active)

Active Comparator group

Description:

TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols.

Treatment:

Device: TMS-fNIRS over the dl-PFC

TMS-fNIRS over the dl-PFC (Sham)

Sham Comparator group

Description:

TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols.

Treatment:

Device: TMS-fNIRS over the dl-PFC