Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy
Condition: Brain Injury, Chronic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Injury, Chronic; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the
      cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain
      injury (TBI). Cognitive function includes such things as thinking, remembering, recognition,
      concentration ability and perception. Traumatic brain injury is common with head injuries
      caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to
      an intervention or sham arm. Computer based cognitive tests will be used as outcome measures.
      Subjects are enrolled by invitation only.
    

Detailed description: 
      The Agency for Healthcare Research and Quality (AHRQ) did a comprehensive review of the
      literature focusing on TBI, stroke and cerebral palsy in Sep 2003. The study design and goals
      were based on the AHRQ recommendations for future hyperbaric oxygen for TBI research. This
      report stated, "The most important gap in the evidence is a lack of a good quality
      time-series study or controlled trial of the effects of HBOT on cognition, memory, and
      functional status in patients with deficits due to mild and moderate chronic TBI." The AHRQ
      Evidence Report further stated, "Lack of agreement on the dosage of HBOT and the duration of
      treatment is an important barrier to conducting good-quality clinical studies…Good-quality
      dose-ranging studies of HBOT for brain injury can be done, based on the model used by
      pharmaceutical manufacturers and the FDA. It is likely that the dosage of HBOT needs to be
      individualized based on the patient's age, clinical condition, and other factors". Although
      there are many anecdotal cases of TBI improvement with HBO, this case is backed with
      non-subjective data. The biological basis for why breathing 100% oxygen under pressurized
      conditions improves chronic neurological trauma remains unclear. There is some evidence that
      chronic TBI effects are related to the demyelization effect linked to the expression of a
      specific protease, calpain. This protease is also seen in demyelination delayed effects of
      carbon monoxide poisoning which is slowed by treatment with HBO. The "idling neuron" theory
      advocated in neurological studies suggest that HBO may increase metabolic performance of
      chronically impaired neurons that were marginally capable, enabling restoration of full
      function leading in turn to increased integrative plasticity. HBO has been shown to increase
      recruitment of stem cells from the bone marrow, suggesting that HBO may increase the rate at
      which damaged neuronal tissue can be reconstituted de novo. The proposed research will treat
      25 subjects using HBO (2.4 ATA breathing 100% oxygen) and 25 subjects in a sham HBO treatment
      (1.3 ATA breathing air). Computer-based cognitive testing and the Post-traumatic Stress
      Disorder Checklist for Military (PCL-M) will be administered pre- and post-HBOT as well as at
      intervals throughout the treatment. The cognitive test results and stem cell results will be
      analyzed within each subject at the various treatment points as well as cohort groups between
      each treatment leg. Cognitive test scores will also be compared to cognitive test population
      reference bases matched for gender and age. The Agency for Healthcare Research and Quality
      2003 report also stated, "If there is a 1 percent chance that the treatment works, a rational
      decision maker would try it-there is a potential gain and no potential loss. On the other
      hand, if there are proven harms, and their severity and frequency are well described, the
      probability that the treatment works would have to be higher before most people would try it"
    

Intervention name(s): Hyperbaric oxygen @ 2.4 ATA; Sham treatment
Intervention type(s): Other; Other
Intervention description(s): Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Other intervention name(s): hyperbaric oxygen; HBOT; HBO; sham exposure; 1.3 ATA air
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: chronic TBI; cognitive function; PTSD; HBO; hyperbaric; oxygen; chronic brain injury