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New treatment option for Traumatic Brain Injury
Official title Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury
ClinicalTrials.gov ID: NCT06581003
What this study is testing
What is Oxygen 99.7 %?
Oxygen 99.7 % is an investigational medicine, being studied as a potential treatment for traumatic brain injury.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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.
You likely can't join if
- Received HBOT within the last 3 months.
- Concurrently enrolled in another clinical trial.
- Pregnancy or plans to become pregnant during the study period.
- Lactating
- History of retinal repair
- Malignancy:
See the full eligibility 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.
- Received HBOT within the last 3 months.
- Concurrently enrolled in another clinical trial.
- Pregnancy or plans to become pregnant during the study period.
- Lactating
- History of retinal repair
- Malignancy:
- Active
- 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)\ Exclusion criteria for fMRI optional sub-study only
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.