Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Hyperbaric Oxygen Therapy on Clinical Symptoms and Markers of Inflammation and Oxidative Stress in Autistic Children: A Pilot Study
Brief Summary: Autism is a neurodevelopmental disorder that currently affects 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 inflammation in the brain, and increased markers of oxidative stress. 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 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.

The purpose of this study is to determine if HBOT improves clinical outcomes in children with autism. The study will also determine if HBOT changes markers of inflammation and oxidative stress in autistic children.


Options:
A: Inclusion Criteria:

1. Diagnosis of DSM-IV defined autism and meets cut off for autism on the Autism Diagnostic Inventory-Revised (ADI-R) or Social Communication Questionnaire (SCQ) and the Autism Diagnostic Observation Scale (ADOS).
2. Age 3 to 8 years.
3. Nonverbal IQ of 50 or above.
4. Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 20 week intervention.

Exclusion Criteria:

1. Clinical evidence of seizure disorder
2. Active infection with fever
3. Fragile X or other known genetic cause of autism
4. Perinatal brain injury (e.g. cerebral palsy)
5. Previous adequate trial (at least 20 session) of HBOT
6. Inability to clear ears in the HBOT chambers
B: Inclusion Criteria:

* Children diagnosed with autism spectrum disorder

Exclusion Criteria:

* Seizures not controlled by medicine
* Inability to ventilate ears
C: Inclusion Criteria:

* Male and female children 2-10 years diagnosed with autism, PDD, or Aspergers
* No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
* No additional biomedical treatments started 6 weeks prior to enrollment
* No changes in dietary management for 3 months prior to enrollment
* Access to Thoughtful House on a daily basis, or as necessary for the study participation
* In addition, the child participant must be:

  * Ambulatory or require minimum support walking, per parent
  * Able to sit still for 5 minutes or longer with a preferred toy item, per parent
  * Adequate vision and hearing for the purposes of test administration, per parent
  * Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent
  * Stable and controlled medical disorder
  * Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures
D: Inclusion Criteria:

* DSM-IV diagnosis of Autistic Disorder, confirmed with Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R)
* HBOT naïve

Exclusion Criteria:

* DSM-IV diagnosis of Pervasive Developmental Disorder other than Autistic Disorder including PDD-NOS (Pervasive Developmental Disorder, not otherwise specified) and Asperger's Syndrome
* Uncontrolled seizures
* Ear infection
* Uncontrolled asthma
* Inability to equalize ear pressure
* Fragile X syndrome
* Current therapy consisting of chelation

Answer: B