RECRUITING

TMS-fNIRS Personalized Dosing

Conditions

Post Traumatic Stress Disorder Traumatic Brain Injury

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

TMS-fNIRS Personalized Dosing

Quick Facts

Study Start:2024-01-19

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05916417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	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).

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

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).

Contacts and Locations

Study Contact

Isabelle Taylor, MA

CONTACT

850-728-3881

fsun@med.fsu.edu

Kevin Johnson, PhD, RN

CONTACT

850-728-3881

fsun@med.fsu.edu

Principal Investigator

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

PRINCIPAL_INVESTIGATOR

Florida State University

Study Locations (Sites)

Isabelle Taylor

Tallahassee, Florida, 32306

United States

Collaborators and Investigators

Sponsor: Florida State University

Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A., PRINCIPAL_INVESTIGATOR, Florida State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-19

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-01-19

Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

Post Traumatic Stress Disorder
Traumatic Brain Injury