TMS-fNIRS Personalized Dosing

NCT ID: NCT05916417

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2026-09-30

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

Post Traumatic Stress Disorder; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

TMS-fNIRS over the dl-PFC (Active)

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.

Group Type: ACTIVE_COMPARATOR

TMS-fNIRS over the dl-PFC

Intervention Type: 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 (Sham)

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.

Group Type: SHAM_COMPARATOR

TMS-fNIRS over the dl-PFC

Intervention Type: 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.

Interventions

TMS-fNIRS over the dl-PFC

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

F. Andrew Kozel

Professor & Mina Jo Powell Endowed Chair, Neurological Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Isabelle Taylor

Tallahassee, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Isabelle Taylor, MA

Role: CONTACT

fsun@med.fsu.edu

850-728-3881

Kevin Johnson, PhD, RN

Role: CONTACT

fsun@med.fsu.edu

850-728-3881

Facility Contacts

Isabelle M Taylor, MA

Role: primary

fsun@fsu.edu

850-728-3881

Kevin Johnson, PhD

Role: backup

fsun@fsu.edu

850-728-3881

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CDMRP-TP220192

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00004007

Identifier Type: -

Identifier Source: org_study_id