Hyperbaric Oxygen Therapy in Chronic Stable Brain Injury
Description:
Hyperbaric oxygen is presently being used in an attempt to improve functional outcome
following a multitude of brain injuries such as stroke, anoxic brain injury, traumatic brain
injury, and others. Family members of brain-injured individuals correspond via the Internet
into coalitions demanding that their loved ones receive hyperbaric oxygen therapy. There are
anecdotal reports of benefit with hyperbaric oxygen following brain injury but there is
little credible scientific evidence for efficacy of hyperbaric oxygen in brain injury.
Clearly, what is needed to answer if hyperbaric oxygen improves brain injury are results from
carefully designed multi-center, prospective, randomized controlled clinical trials. However,
the implementation of such a Phase III clinical trial is challenging without information from
Phase II trials. We propose to conduct a feasibility trial that may potentially guide a
future Phase III clinical trial.
Mechanisms by which hyperbaric oxygen improves sequelae following brain injury are
speculative. Hyperbaric oxygen upregulates growth factor receptor sites on human endothelium
and can stimulate healing in hypoxic wounds. It is conceivable that hyperbaric oxygen exerts
similar effects within damaged neuronal tissue but this information is lacking. Stem cells
are present in the adult brain and there is speculation that hyperbaric oxygen may stimulate
these stem cells to generate new neurons, but once again, this information is speculative.
In this Phase II feasibility prospective clinical trial, we propose to recruit and enroll 70
brain-injured subjects and expose them daily to hyperbaric oxygen at 1.5 atmospheres absolute
for 60 minutes per session, for 60 sessions per subject. This research protocol is the one
most commonly used by practitioners who claim benefit with hyperbaric oxygen therapy. Before
and after the 60 hyperbaric oxygen sessions, and at 6 months following completion of
hyperbaric oxygen, outcome measures consisting of neuropsychological testing, functional
measures, health-related quality of life measures, and a neurological examination will be
conducted and analyzed with the subjects serving as their own controls. Important information
regarding a subsequent Phase III clinical trial, including subject recruitment, tolerance and
risk of therapy, dropout rate, and potential benefit or lack of benefit with hyperbaric
oxygen will be reported.
Condition:
Brain Injury
Treatment:
Hyperbaric oxygen therapy (HBO2)
Start Date:
November 2003
Sponsor:
Intermountain Health Care, Inc.
For More Information:
https://clinicaltrials.gov/show/NCT00830453