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TMS-fNIRS over the dl-PFC (Active) for Traumatic Brain Injury

N/A

Recruiting

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

Research Sponsored by Florida State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults ages 18-70 years

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 3-33

Awards & highlights

Study Summary

This trial aims to test a new technology called personalized TMS-fNIRS in patients with PTSD and mild TBI. The technology combines transcranial magnetic stimulation and functional near-infrared spectroscopy to

Who is the study for?

This trial is for adults aged 18-70 with PTSD, who may also have mild TBI. Participants must be eligible for TMS treatment, diagnosed with PTSD using CAPS-5, and on a stable psychotropic medication or psychotherapy regimen for at least one month prior to the study.Check my eligibility

What is being tested?

The study tests personalized TMS-fNIRS technology as a potential replacement for indirect motor threshold procedures in dosing TMS. It aims to directly measure frontal brain activity in patients with depression, PTSD, or TBI.See study design

What are the potential side effects?

While not explicitly listed here, common side effects of TMS can include headache, scalp discomfort during stimulation, lightheadedness, and rare risk of seizure. fNIRS is generally considered safe but might cause slight discomfort where sensors are placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I understand the study details and can follow its requirements.

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My mental health medication has been stable for the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 3-33

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 3-33

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3-33 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TMS-fNIRS over the dl-PFC (Active)Active Control1 Intervention

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 II: TMS-fNIRS over the dl-PFC (Sham)Placebo Group1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Florida State UniversityLead Sponsor

200 Previous Clinical Trials

31,698 Total Patients Enrolled

Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A.Principal InvestigatorFlorida State University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to enroll in this ongoing trial?

"As per clinicaltrials.gov, this medical trial is actively seeking candidates. The information was first shared on January 19th, 2024 and last revised on February 13th of the same year."

Answered by AI

What is the current number of individuals eligible for enrollment in this clinical research study?

"Affirmative. The details on clinicaltrials.gov specify that this trial is actively enrolling subjects. It was first listed on January 19, 2024, with the most recent update made on February 13, 2024. Recruitment aims to include 60 participants at a single site."

Answered by AI

Are individuals older than 55 years being sought for recruitment in this study?

"Individuals aged between 18 and 70 are sought for participation in this trial. Interestingly, there are a total of 99 trials catering to those under 18 years old and an additional 565 trials specifically targeting individuals over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TMS-fNIRS Personalized Dosing

F. Andrew Kozel 2024. "TMS-fNIRS Personalized Dosing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05916417.