Hyperbaric Oxygen Therapy for Traumatic Brain Injury

Recruiting at 7 trial locations

Overseen By Frederick Korley, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Profound anemia, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 54

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how hyperbaric oxygen therapy (breathing pure oxygen in a pressurized room) can aid individuals with severe traumatic brain injury (TBI). Researchers aim to determine if certain blood proteins can predict who will benefit from this treatment and how it influences recovery. The goal is to enhance future treatment efficiency by identifying patients likely to improve. Participants must be part of an ongoing severe TBI treatment study but cannot join if they have extremely low red blood cell counts requiring a transfusion or if blood samples cannot be taken. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that hyperbaric oxygen therapy is likely to be safe for humans?

Research has shown that hyperbaric oxygen therapy (HBOT) is generally safe for most people. Most side effects are mild and temporary, with serious side effects being rare. During HBOT, patients breathe pure oxygen in a pressurized chamber, which can sometimes cause issues like ear pressure or temporary changes in vision, but these usually resolve on their own.

In past studies, HBOT was safely used for conditions like radiation proctitis, where it improved healing. This indicates that the treatment is well-tolerated when used correctly.

However, while HBOT is safe for many, it may not be suitable for everyone. Consulting a healthcare provider is essential to ensure it is appropriate for individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about hyperbaric oxygen therapy for brain injuries because it offers a unique approach compared to conventional treatments like rest and medication to manage symptoms. Unlike these standard options that primarily focus on symptom management, hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized chamber. This process increases oxygen delivery to injured brain tissue, potentially enhancing healing and recovery. This method not only targets the injury directly but might also accelerate the recovery process, offering hope for quicker and more effective rehabilitation.

What evidence suggests that Hyperbaric Oxygen Therapy might be an effective treatment for severe traumatic brain injury?

Research has shown that hyperbaric oxygen therapy (HBOT) can deliver more oxygen throughout the body, potentially aiding in the treatment of severe traumatic brain injury (TBI). Studies have found that HBOT may improve survival rates and reduce death rates in other conditions by providing pure oxygen at higher-than-normal air pressure. Evidence also suggests that HBOT can enhance the quality of life for patients with long-term health issues. Although specific data for severe TBI remains limited, the mechanism of HBOT is promising. This therapy is already considered safe for FDA-approved uses, with few complications reported. ^{2 6 7 8 9}

Who Is on the Research Team?

William Barsan, MD

Principal Investigator

University of Michigan

Gaylan Rockswold, MD, PhD

Principal Investigator

Hennepin Healthcare

Byron Gajewski, PhD

Principal Investigator

University of Kansas

Frederick Korley, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Inclusion Criteria

Enrolled in HOBIT (this is an ancillary study to the HOBIT Trial)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Biospecimen Collection

Initial set of biospecimens (serum, plasma, CSF, DNA) are collected as soon as feasible after randomization, but no later than 24 hours from injury

24 hours

Multiple collections within 24 hours

Acute Biomarker Monitoring

Biospecimens are obtained every 8 hours for the first 24 hours post-enrollment to characterize acute changes in biomarker levels

24 hours

Multiple collections within 24 hours

Sub-acute Biomarker Monitoring

Biospecimens are obtained on study days 2, 3, 5, 7, and 14 to characterize sub-acute changes in biomarker levels

2 weeks

5 visits (in-person)

6-Month Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood collection at the 6-month visit

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury

Approved in European Union as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury
• Diabetic foot ulcers

Approved in Canada as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing
• Radiation injury

Approved in Japan as Hyperbaric Oxygen Therapy for:

• Decompression sickness
• Gas gangrene
• Carbon monoxide poisoning
• Wound healing

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8465921/

A General Overview on the Hyperbaric Oxygen Therapy A sepsis mouse model showed a significant increase in survival rate, >50%, with early HBOT compared to a control group that did not receive the treatment and ...

2. nature.com nature.com/articles/s41598-024-53091-3

Long term outcomes of hyperbaric oxygen therapy in post ... The results indicate HBOT can improve the quality of life, quality of sleep, psychiatric and pain symptoms of patients suffering from long COVID.

3. wjes.biomedcentral.com wjes.biomedcentral.com/articles/10.1186/s13017-023-00490-y

The effect of hyperbaric oxygen therapy on the clinical ... As the primary outcome, the mortality rate was reported in all included studies. The mean mortality rate in the HBO group was 10.6% [95% CI (6.7 ...

4. health.harvard.edu health.harvard.edu/staying-healthy/hyperbaric-oxygen-therapy-evidence-based-uses-and-unproven-claims

Hyperbaric oxygen therapy: Evidence-based uses and ... Hyperbaric oxygen therapy for FDA-approved conditions is considered safe. Complications of HBOT are uncommon, but they can occur. These include ...

5. mayoclinic.org mayoclinic.org/tests-procedures/hyperbaric-oxygen-therapy/about/pac-20394380

Hyperbaric oxygen therapy Hyperbaric oxygen therapy increases delivery of oxygen to the body by providing pure oxygen in an enclosed space with higher than normal air pressure.

6. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/complications-of-hyperbaric-oxygen-treatment

Complications of Hyperbaric Oxygen Treatment You breathe pure oxygen inside a highly pressurized chamber during hyperbaric oxygen therapy (HBOT). ... Hyperbaric oxygen therapy is not safe for everyone.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5467109/

Hyperbaric Oxygen Therapy: Side Effects Defined and ... HBOT remains among the safest therapies used today. Nonetheless, there are side effects associated with HBOT. It is important for providers to be able to ...

8. fda.gov fda.gov/consumers/consumer-updates/hyperbaric-oxygen-therapy-get-facts

Hyperbaric Oxygen Therapy: Get the Facts Hyperbaric Oxygen Therapy (HBOT) devices only considered safe and effective for certain conditions. The FDA recommends you use a HBOT device ...

9. aetna.com aetna.com/cpb/medical/data/100_199/0172.html

Hyperbaric Oxygen Therapy (HBOT) The investigators found HBOT significantly improved chance of healing for radiation proctitis (relative risk 2.7, 95% confidence interval [CI]: 1.2 to 6.0). The ...