What is the mechanism of action of this treatment?

Hyperbaric oxygen therapy (HBOT) is a treatment for traumatic brain injury (TBI) that involves breathing pure oxygen in a pressurized environment. This increases the amount of oxygen in the blood, which can enhance oxygen delivery to injured brain tissues, reduce swelling, and support cellular repair processes. This is particularly important for TBI patients as it can help mitigate secondary brain damage and improve overall recovery. Other common treatments for TBI include medications to manage symptoms like pain and seizures, and surgical interventions to relieve intracranial pressure, all aimed at stabilizing the patient and promoting brain healing.

What side effects are associated with this type of intervention?

Common treatments for Traumatic Brain Injury (TBI) include medications to manage symptoms, surgical interventions, and supportive therapies like hyperbaric oxygen treatment (HBOT). HBOT, which increases oxygen delivery to injured tissues, is being studied for its potential benefits in TBI. Known side effects of HBOT can include barotrauma to the ears and sinuses, oxygen toxicity, and claustrophobia. Other treatments for TBI, such as medications, may cause side effects like dizziness, nausea, and increased risk of infections. Surgical interventions carry risks of infection, bleeding, and complications related to anesthesia.

What prior FDA approvals exist?

As of now, there are no FDA-approved drugs specifically for the treatment of Traumatic Brain Injury (TBI). Treatments primarily focus on managing symptoms and preventing secondary injury. Hyperbaric oxygen therapy, which is being studied for its potential to improve outcomes in TBI by increasing oxygen delivery to injured tissues, is not yet FDA-approved for this indication. Current management strategies for TBI include supportive care, such as maintaining adequate oxygenation and blood flow to the brain, and addressing complications like intracranial pressure.

What other types of research exist?

Promising novel alternatives to Hyperbaric Oxygen Treatment for Traumatic Brain Injury patients include: 1) Pharmacological agents such as Edaravone, which has shown efficacy in reducing oxidative stress and improving outcomes in neurological injuries. 2) Antisense oligonucleotide therapies targeting specific genetic expressions involved in injury response. 3) Advanced neuroprotective strategies like the use of Aquaporin-4 (AQP-4) and Matrix Metalloproteinase-9 (MMP-9) inhibitors, which have demonstrated potential in reducing brain edema and blood-brain barrier disruption. 4) Emerging therapies like Boron Neutron Capture Therapy (BNCT), which is being explored for its targeted radiotherapeutic effects in brain injuries.

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Procedure

Hyperbaric Oxygen Therapy for Traumatic Brain Injury (HOBIT Trial)

Phase 2

Recruiting

Led By Byron Gajewski, Ph.D.

Research Sponsored by Hennepin Healthcare Research Institute

Eligibility Criteria Checklist

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

Must have

Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8

Must not have

Cardiopulmonary resuscitation performed

Coma suspected to be due to primarily non-TBI causes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find the best way to use hyperbaric oxygen treatment for patients with severe brain injuries. The treatment involves breathing pure oxygen at high pressure to help heal the brain. Researchers want to determine the safest and most effective settings for this treatment. Hyperbaric oxygen therapy is an existing and approved treatment for various medical conditions, including decompression sickness, air or gas embolism, and carbon monoxide poisoning.

Who is the study for?

This trial is for people aged 16-65 with severe traumatic brain injury (TBI), defined as a Glasgow Coma Scale score of 3 to 8. They must be able to start treatment within 8-14 hours after admission, depending on whether they've had major surgery like craniotomy. Excluded are those who can't start treatment within 24 hours, have non-TBI related coma, penetrating head injuries, pre-existing neurological diseases, unstable spinal cord injury, fixed coagulopathy or severe hypoxia.

What is being tested?

The study tests different hyperbaric oxygen treatments for TBI patients. It aims to find the best combination of pressure levels and normobaric hyperoxia that could improve outcomes in future trials. Treatments vary from usual care to several combinations of hyperbaric oxygen at pressures between 1.5 ATA and 2.5 ATA with or without additional normobaric hyperoxia.

What are the potential side effects?

Possible side effects include ear pain due to pressure changes, temporary vision changes, lung collapse if air gets trapped during decompression (rare), fatigue and headaches post-treatment.

Eligibility Criteria

Inclusion Criteria

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

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My severe brain injury score is between 3 to 8.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have undergone CPR.

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My coma is thought to be caused by something other than a brain injury.

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I have a brain condition like a stroke or TBI that affects my movement or thinking.

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I have a recent, unstable injury to my spinal cord.

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I have severe difficulty breathing.

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My blood clotting disorder is stable.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Brain tissue partial pressure of oxygen

Duration of ICP elevation

Peak brain tissue oxygen (P02) during HBO treatments

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Normobaric Hyperoxia (NBH)Experimental Treatment1 Intervention

Normobaric Hyperoxia (NBH meaning 100% O2 at 1.0 ATA) for 4.5 hours twice a day for 5 days.

Group II: Hyperbaric oxygen (2.5 ATA, no NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 2.5 ATA for 1 hour, without NBH. This treatment is administered twice a day for 5 days.

Group III: Hyperbaric oxygen (2.5 ATA + NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 2.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Group IV: Hyperbaric oxygen (2.0 ATA, no NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 2.0 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.

Group V: Hyperbaric oxygen (2.0 ATA + NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 2.0 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Group VI: Hyperbaric oxygen (1.5 ATA, no NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 1.5 ATA for 1 hour without NBH. This treatment is administered twice a day for 5 days.

Group VII: Hyperbaric oxygen (1.5 ATA + NBH)Experimental Treatment1 Intervention

Hyperbaric oxygen at 1.5 ATA for 1 hour and NBH for 3 hours. This treatment is administered twice a day for 5 days.

Group VIII: Usual careActive Control1 Intervention

Usual care for severe TBI

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hyperbaric oxygen therapy (HBOT) is a treatment for traumatic brain injury (TBI) that involves breathing pure oxygen in a pressurized environment. This increases the amount of oxygen in the blood, which can enhance oxygen delivery to injured brain tissues, reduce swelling, and support cellular repair processes. This is particularly important for TBI patients as it can help mitigate secondary brain damage and improve overall recovery. Other common treatments for TBI include medications to manage symptoms like pain and seizures, and surgical interventions to relieve intracranial pressure, all aimed at stabilizing the patient and promoting brain healing.