Traumatic Brain Injury (TBI)

Hyperbaric Oxygen Therapy Approval Status

No Clearance by US Food and Drug Administration (FDA)

No Approval by the Undersea and Hyperbaric Medical Society (UHMS)

! Read the US Food and Drug Administration (FDA) position paper on off-label hyperbaric treatment:
Hyperbaric Oxygen Therapy: Don't Be Misled, published 22 August 2013.

About Clearance and Approval


Definition and Causes

Traumatic brain injury (TBI) is damage to the brain by an external force, including wounds that penetrate the skull and closed head injuries (CHIs). The brain is quite easily injured by direct impact, whether a sharp or a blunt force, or by sudden acceleration of the head.

About 1.7 million Americans a year suffer a TBI and half a million are hospitalized. Most (75%) are mild brain injuries or concussions. [ CDC, 2013 ] Head injury is a leading cause of death and disability for infants and children, whose developing brains are more fragile. [ Brain, 2001 ] Even minor brain injuries in youth may cause dementia in later life. Improved treatments and safety equipment have led to fewer TBI deaths but more disabilities in recent decades. Many survivors face serious rehabilitation challenges and lifelong physical, cognitive, emotional, and behavioral problems.

Common causes of traumatic brain injury (TBI) include vehicular accidents, falls, sports injuries, explosions, gunshots, and violent blows. Mild TBI or concussion may cause a loss of consciousness for just a few seconds or minutes. Moderate or severe TBI may cause prolonged loss of consciousness or memory. Intracranial pressure and ischemia (vascular bleeding or clotting) may cause further brain damage or death days after the injury.

Evidence Index

FDA cleared, widely reimbursed
Strong body of evidence
Repeatedly favorable results
Early or mixed results
Unfavorable or no evidence
Strong evidence against HBOT

Treatment with Hyperbaric Oxygen Therapy

In randomized clinical trials hyperbaric oxygen therapy (HBOT) has been shown to significantly reduce the risk of death in patients with traumatic brain injury, but there is little evidence survivors enjoy good outcomes. [ Cochrane, 2012 ]

HyperbaricLink Commentary

A signature wound of the wars in Afghanistan and Iraq, and a hot topic in youth sports and college and professional football, TBI has become an especially active area of political action and HBOT research. But the earliest published results on HBOT for mild TBI sponsored by the US Department of Defense and Veterans Health Administration [ Journal of Head Trauma Rehabilitation, 2013 ] have been profoundly disappointing, prompting us to lower our Evidence Index score to Scant.

Even more disappointing has been the scramble for scarce research funds and the solicitation of brain-injured trial subjects by some unqualified providers and practitioners. Patients should avoid hyperbaric treatment centers requiring a fee for investigational TBI treatment. And surely there is no place for “mild HBOT” inflatable devices in the treatment of such a serious condition.

Patient Resources

HyperbaricLink recommends the following websites for anyone seeking authoritative information, patient advocacy, and community support for traumatic brain injury.

Brain Injury Association of America

The United States' oldest and largest brain injury advocacy organization, BIAA supports prevention, research, treatment, and education.

Read an introduction to Living With Brain Injury.


A national multimedia project sponsored by WETA public television, Washington DC, offers information and resources about preventing, treating, and living with TBI.

Visit the special section BrainLineMilitary.

Polytrauma/TBI System of Care
US Veterans Administration

Providing comprehensive and high-quality care for military veterans and servicemembers, the VA Polytrauma/TBI System of Care (PSC) coordinates benefits, services, and facilities for the treatment of TBI.
Access VA resources at Make The Connection.

Defense Centers of Excellence for
Psychological Health and Traumatic Brain Injury (DCoE)

US Department of Defense

DCoE offers resources for service members, families, and veterans and works to enhance TBI awareness and improve the DoD system of care.

Find more resources at Defense and Veterans Brain Injury Center.

Clinical Resources

Start with the following resources to explore current research activities and the peer-reviewed medical literature on hyperbaric oxygen therapy for traumatic brain injury.

 Use the search buttons below to go directly to research on hyperbaric oxygen therapy.


An independent, international, nongovernmental organization, Cochrane is a powerful force in evidence-based medicine. One may consider a Cochrane article on any HBOT topic required reading.

Read the 2012 Cochrane Intervention Review: Hyperbaric oxygen therapy for the adjunctive treatment of traumatic brain injury  from the Cochrane Injuries Group, doi:10.1002/14651858.CD004609.pub3
US National Institutes of Health keeps the official list of human clinical trials currently enrolling, in progress, and recently completed. One may reasonably question the size and legitimacy of any study not listed here.


Google Scholar

A specialized Google search engine, Google Scholar indexes scholarly articles, patents, and legal opinions and journals. Google Scholar may produce many search results, but entries provide easy access to full-text journal articles.

Search Google Scholar


HBOEvidence uses computerized tools to appraise the key randomized controlled trials (RCTs) in the hyperbaric medical literature. One may reasonably question the overall strength of HBOT evidence for any disease or condition not covered here.

Read the HBOEvidence appraisals for treatment of head injury.
US National Library of Medicine, US National Institutes of Health

PubMed keeps the official list of scientific papers published in reputable peer-reviewed medical journals. One may reasonably question the importance and legitimacy of any study not listed here.



News About Traumatic Brain Injury and Hyperbaric Oxygen Therapy

Detecting Traumatic Brain Injuries in the Living

Friday, 12/6

At present, a definitive determination that a person has suffered from chronic traumatic encephalopathy (CTE) can only be made after death. The accumulation of tau proteins that result from traumatic brain injury (TBI) are not d read more...

Update: Hyperbaric Oxygen Therapy for Traumatic Brain Injury (TBI)

Tuesday, 11/26

We have updated and upgraded our traumatic brain injury (TBI) page. In randomized clinical trials hyperbaric oxygen therapy (HBOT) has been shown to significantly reduce the risk of death in patients with traumatic brain injury, read more...

Freezer Malfunction at Harvard Tissue Bank a Setback for Autism and Other Brain Research

Thursday, 6/14

A freezer and alarm failure, causing severe damage to one-third of the frozen brain tissue specimens stored at one Harvard Brain Bank center at McLean Hospital in Belmont, Massachusetts, a collection owned by Autism Speaks, is a read more...

More news from O2.0 – the HyperbaricLink blog

Complete traumatic brain injury news archive from O2.0 — the HyperbaricLink blog

Further Learning

HyperbaricLink suggests the following resources for those interested in learning more about traumatic brain injury:

League of Denial: The NFL, Concussions, and the Battle for Truth
by Mark Fainaru-Wada and Steve Fainaru
(Three Rivers Press, 2014).
PBS Video: League of Denial: The NFL's Concussion Crisis

Brain Wars: How the Military Is Failing Its Wounded
by National Public Radio and ProPublica.

Related Terms


US Centers for Disease Control and Prevention, Injury Prevention & Control, Traumatic Brain Injury. Retrieved 02 May 2015.
US National Institute of Neurological Disorders and Stroke, Traumatic Brain Injury Information Page. Retrieved 05 November 2013.
Page Data
Updated: 26 Jul 2015 05:04 PM
Created: 16 Oct 2009 12:00 AM
By: About the authors »