Clinical Trial – Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

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.

Hyperbaric oxygen therapy might improve certain pathophysiological findings in autism.

Autism is a neurodevelopmental disorder currently affecting as many as 1 out of 166 children in the United States. Numerous studies of autistic individuals have revealed evidence of cerebral hypoperfusion, neuroinflammation and gastrointestinal inflammation, immune dysregulation, oxidative stress, relative mitochondrial dysfunction, neurotransmitter abnormalities, impaired detoxification of toxins, dysbiosis, and impaired production of porphyrins. Many of these findings have been correlated with core autistic symptoms. For example, cerebral hypoperfusion in autistic children has been correlated with repetitive, self-stimulatory and stereotypical behaviors, and impairments in communication, sensory perception, and social interaction.

Clinical Trial – A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children

Autism is a neurodevelopmental disorder currently affecting as many as 1 out of 166 children
in the United States. Autism is considered by many to be a permanent condition with little
hope for improvement. Treatment for autism is centered on special schooling and behavioral
therapy; medical science currently has little to offer. Recent research has discovered that
some autistic individuals have decreased blood flow to the brain, evidence of
gastrointestinal and brain inflammation, increased markers of oxidative stress, and a
relative mitochondrial dysfunction. Hyperbaric oxygen therapy (HBOT) can compensate for
decreased blood flow by increasing the oxygen content of plasma and body tissues and can even
normalize oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT
has potent anti-inflammatory effects and reduces oxidative stress. Furthermore, recent
evidence demonstrates that HBOT increases the production of mitochondria and mobilizes stem
cells from human bone marrow, which may aid recovery in neurodegenerative diseases. Based
upon these findings, it is hypothesized that HBOT will improve symptoms in autistic
individuals.

Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic
children. We recently completed a prospective pilot trial using HBOT in 18 children which
demonstrated significant clinical improvements in autistic children on several standardized
scales. Most of the scales were parent-rated, although some were rated by teachers. However,
parents were not blinded to the fact that their children received HBOT and evaluation of the
children was through parent-rated scales, either of which could lead to bias. There was no
placebo or control group. Therefore, the improvements found in this prospective study could
have been due merely to chance or the natural development of the children. To determine if
HBOT improves symptoms in autistic children, a double-blind controlled study is needed.