Tampa, FLNCT06581003Now EnrollingIRB Ready

Traumatic Brain Injury Clinical Trial in Tampa, FL

Access cutting-edge traumatic brain injury treatment through this phase 3 clinical trial at a research site in Tampa. Study-provided care at no cost to qualified participants.

Sponsored by University of South Florida

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Expert Care in Tampa

Access traumatic brain injury specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related traumatic brain injury treatment provided free

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Check if you qualify for this traumatic brain injury clinical trial in Tampa, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Tampa

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Tampa site if eligible
  4. 4Begin participation

About This Traumatic Brain Injury Study in Tampa

The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are: * Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms? (Aim 1) * How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2) * Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms? (Aim 3) Exploratory objectives will explore if there are changes in: 1.) cognitive functioning using neuropsychological tests and the National Institutes of Health (NIH) toolbox, 2.) inflammation biomarkers in blood, 3.) microbiome in stool samples, 4.) electroencephalogram (EEG), 5.) sleep characteristics, and 6.) fMRI. Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen. Participants will: 1. Complete baseline assessments to determine eligibility. 2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks. 3. Complete questionnaires and interviews throughout the course of the study. 4. Complete a 2-week post treatment visit

Sponsor: University of South Florida

Who Can Participate

Inclusion Criteria

U.S. Service Members and Veterans, between 18 and 75 years of age
Ability to read, write, and speak English.
Ability to provide informed consent.
History of TBI. Participants must have a minimum of 1 year post injury and a TBI classified as mild to moderate as determined by with the Ohio State University TBI Identification Method (Bogner, 2009).
Experiencing chronic symptoms of TBI as determined by at least a NSI total score of ≥22 (based on previous work using this score; Harch et al., 2020.
Able to tolerate the HBOT environment lying down for one hour.

Exclusion Criteria

Received HBOT within the last 3 months.
Concurrently enrolled in another clinical trial.
Pregnancy or plans to become pregnant during the study period.
History of retinal repair
Malignancy:
Tumor-related chemotherapy within the prior 6 months
Therapeutic radiation to the central nervous system within the prior year
Current diagnosis of bipolar disorder type I or schizophrenia as determined by responses to inquiry: Have you ever been diagnosed or prescribed medications for bipolar disorder or schizophrenia?
Chronic use of supplemental oxygen or hypoxemia while breathing room air.
Untreated asthma/Bronchial obstruction/pulmonary blebs, recent/untreated pneumothorax
Congestive heart failure with ejection fraction \< 40%
Any implanted devices not cleared for hyperbaric pressurization\*.
Epilepsy and/ or seizures
Scuba diving within the previous month
Current suicidal intent as measured by ≥ 3 on the Columbia-Suicide Severity Rating Scale Screener
Trapped gas observed indicating Bronchospasm present Tension Pneumothorax
Evidence of Noncompliant TM (Until corrected)
Evidence of Pneumothorax
Evidence of Upper Respiratory Tract Infections
Signs and symptoms of viral infections, such as high fevers
Emphysema with CO2 retention
Optic Neuritis
Congenital spherocytosis
History of middle ear surgery / disorders
Pneumocephalus
Optional stool samples will not be collected if someone has diarrhea, vomiting, and took antibiotics in the past 30 days.
Antabuse because it predisposes to oxygen toxicity.
Other medications that would predispose to oxygen toxicity or known to increase drug toxicity will also be excluded. These are: Disulfuram, Acetazolamide, Sulfamylon; bleomycin, cisplatin, and doxyrubicin.
Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)\

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Tampa?

Yes, this clinical trial (NCT06581003) has an active research site in Tampa, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Traumatic Brain Injury Treatment Options in Tampa, FL

If you're searching for traumatic brain injury treatment options in Tampa, FL, this clinical trial (NCT06581003) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Tampa research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced traumatic brain injury specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all traumatic brain injury clinical trials near you to find additional studies recruiting in your area.

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