TMS-fNIRS Personalized Dosing

Not Applicable

Recruiting

• Conditions: Post Traumatic Stress Disorder; Traumatic Brain Injury
• Interventions: Device: TMS-fNIRS over the dl-PFC

• Registration Number: NCT05916417
• Lead Sponsor: Florida State University

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-23
• Study Start: 2024-01-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMS-fNIRS over the dl-PFC (Active)	TMS-fNIRS over the dl-PFC	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.
TMS-fNIRS over the dl-PFC (Sham)	TMS-fNIRS over the dl-PFC	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.

Primary Outcome Measures

Name	Time	Method
TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)	Months 3-33	The magnitude of brain activation based on fNIRS signal for the respective cortices at the individual level will be assessed and compared for the MC and dl-PFC.

Trial Locations

Locations (1)

Isabelle Taylor; 🇺🇸 Tallahassee, Florida, United States