Treatment of Moderate to Mild Cognitive Dysfunction Caused by Traumatic Brain Injury (TBI) With Hyperbaric Oxygen Therapy (HBOT)
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"
Condition:
Brain Injury, Chronic
Treatment:
Hyperbaric oxygen @ 2.4 ATA
Start Date:
February 2009
Sponsor:
San Antonio Military Medical Center
For More Information:
https://clinicaltrials.gov/show/NCT00810615