Hyperbaric Oxygen Brain Injury Treatment Trial

This study is testing different ways to give hyperbaric oxygen (HBO) treatment for severe traumatic brain injury (TBI). HBO involves breathing pure oxygen in a special pressurized room. Researchers want to find the best combination of oxygen pressure (1.5, 2.0, or 2.5 ATA) and whether adding NBH (a specific treatment given after HBO) improves recovery. You might be able to join if you are 16-65 years old and have a severe TBI. The main goal is to see if these treatments improve your recovery, measured by a scale called the Glasgow Outcome Scale Extended (GOS-E) six months after treatment. The study is currently unclear on its status and plans to enroll 200 participants.

Study design
This is an interventional study planning to enroll 200 participants. It is designed to compare several different hyperbaric oxygen treatment approaches.
What's involved
Participants will receive hyperbaric oxygen treatment twice a day for five days, or until they are following commands or brain dead. Some treatments will also include NBH for 3 hours after the HBO session.
Compensation
Not stated in the trial record.
Follow-up
Your recovery will be assessed at 6 months after treatment using the Glasgow Outcome Scale Extended (GOS-E).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02407028

Hyperbaric Oxygen Brain Injury Treatment Trial

Recruiting
PHASE2Ages 16–65InterventionalTreatment
Gaylan Rockswold
~200 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Hyperbaric oxygen (1.5 ATA, no NBH)Hyperbaric oxygen (2.0 ATA, no NBH)Hyperbaric oxygen (2.5 ATA, no NBH)Hyperbaric oxygen (1.5 ATA + NBH)Hyperbaric oxygen (2.0 ATA + NBH)Hyperbaric oxygen (2.5 ATA + NBH)

At a glance

Recruiting sites
8 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Glasgow Outcome Scale Extended (GOS-E)
Measured over Assessment at 6 months
Traumatic Brain Injury
11 sites across 11 states
California1
Florida1
Iowa1
Kentucky1
Maryland1
Michigan1
Minnesota1
Nebraska1
  • Gaylan L Rockswold, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Hennepin County Medical Center, Minneapolis
  • William Barsan, MD · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Byron Gajewski, Ph.D. · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center
  • Frederick K Korley, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · University of Michigan

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Eligibility criteria

Inclusion

Age 16 years or older and 65 years or younger
Present with severe TBI, defined as Glasgow Coma Scale (GCS) of 3 to 8.
Marshall computerized tomography (CT) score \>1 in patients with a GCS of 7 or 8 or patients with an alcohol level \>200 mg/dl
Ability to initiate the first hyperbaric oxygen treatment within 8 hours of admission in patients not requiring a craniotomy/craniectomy or any other major surgical procedure OR
Ability to initiate the first hyperbaric oxygen treatment within 14 hours of admission in patients requiring a craniotomy/craniectomy or major surgical procedure

Exclusion

First hyperbaric oxygen treatment cannot be initiated within 24 hours of injury
GCS of 3 with mid-position and non-reactive pupils bilaterally (4mm)
Penetrating head injury
Pregnant
Pre-existing neurologic disease (e.g. TBI or stroke or neurodegenerative disorder) with confounding residual neurologic deficits
Unstable acute spinal cord injury
Fixed coagulopathy
Severe hypoxia
Cardiopulmonary resuscitation performed
Coma suspected to de due to primarily non-TBI causes
Any contraindications to the study intervention
  • Glasgow Outcome Scale Extended (GOS-E)Assessment at 6 months