TMS-fNIRS Personalized Dosing

NCT05916417 | Recruiting FDA Device

• 2 other identifiers: STUDY00004007CDMRP-TP220192
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Traumatic Brain Injury; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)

  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.

  Months 3-33

Study Arms (2)

TMS-fNIRS over the dl-PFC (Active)

ACTIVE COMPARATOR

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.

Device: TMS-fNIRS over the dl-PFC

TMS-fNIRS over the dl-PFC (Sham)

SHAM COMPARATOR

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.

Device: TMS-fNIRS over the dl-PFC

Interventions

TMS-fNIRS over the dl-PFC DEVICE

Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light.

TMS-fNIRS over the dl-PFC (Active); TMS-fNIRS over the dl-PFC (Sham)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18-70 years.
• Eligible for consideration of treatment with TMS for PTSD.
• Diagnosis of PTSD based on CAPS-5.
• 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.
• 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

You may not qualify if:

• Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
• Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate).
• Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
• Dementia or other cognitive disorder making unable to engage in study.
• Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
• Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
• OCD cannot be the primary disorder but can have OCD symptoms
• Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
• Current, planned, or suspected pregnancy
• 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.)
• Severe Traumatic Brain Injury
• Prior TMS treatment or already received TMS as part of a study.
• 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.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Isabelle Taylor

Tallahassee, Florida, 32306, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A.

  Florida State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle Taylor, MA

CONTACT

850-728-3881; fsun@med.fsu.edu

Kevin Johnson, PhD, RN

CONTACT

850-728-3881; fsun@med.fsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding Procedures The participants, PI, Research Staff involved in TMS treatment, and staff performing the study procedures will be blinded to the participant's dl-PFC protocol assignment throughout the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Mina Jo Powell Endowed Chair, Neurological Sciences

Model Details: 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).

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 23, 2023
• Study Start: January 19, 2024
• Primary Completion: June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)