TMS-fNIRS Personalized Dosing

Traumatic Brain Injury Clinical Trial

Official title:

TMS-fNIRS Personalized Dosing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05916417
• Other study ID #: STUDY00004007
• Secondary ID: CDMRP-TP220192
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2023
• Source: Florida State University
• Contact: Isabelle Taylor, MA
• Phone: 850-728-3881
• Email: fsun[@]med.fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Isabelle Taylor	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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