TMS-fNIRS Personalized Dosing

• Sponsor: Florida State University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05916417
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder; Traumatic Brain Injury	Device: TMS-fNIRS over the dl-PFC	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).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).
• Masking: Double (Participant, Investigator)
• Masking Description: 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.
• Primary Purpose: Other
• Official Title: TMS-fNIRS Personalized Dosing
• Anticipated Study Start Date: Sep 30, 2023
• Anticipated Primary Completion Date: Aug 1, 2025
• Anticipated Study Completion Date: Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Sham Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures

1. TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC) [Months 3-36]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Florida State University

Investigators

• Principal Investigator: Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A., Florida State University

Study Documents (Full-Text)

• Informed Consent Form - May 10, 2023

More Information

Publications

None provided.

• Responsible Party: F. Andrew Kozel, Professor & Mina Jo Powell Endowed Chair, Neurological Sciences, Florida State University
• ClinicalTrials.gov Identifier: NCT05916417
• Other Study ID Numbers: STUDY00004007
• First Posted: Jun 23, 2023
• Last Update Posted: Jun 26, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Jun 26, 2023