A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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, static 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 cerebral perfusion, evidence of
      gastrointestinal and neuro-inflammation, increased markers of oxidative stress, and a
      relative mitochondrial dysfunction. Multiple independent single photon emission computed
      tomography (SPECT) and positron emission tomography (PET) research studies have revealed
      hypoperfusion to several areas of the autistic brain, most notably the temporal regions and
      areas specifically related to language comprehension and auditory processing. Several studies
      show that diminished blood flow to these areas correlates with many of the clinical features
      associated with autism including repetitive, self-stimulatory and stereotypical behaviors,
      and impairments in communication, sensory perception, and social interaction. Hyperbaric
      oxygen therapy (HBOT) has been used with clinical success in several cerebral hypoperfusion
      syndromes including cerebral palsy, fetal alcohol syndrome, closed head injury, and stroke.
      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 statistically 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 indicated.
    

Intervention name(s): Hyperbaric Therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment