Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Double-Blind, Controlled Study on the Clinical Effects of Hyperbaric Therapy in Autistic Children
Brief 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.


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:

* 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
C: Inclusion Criteria:

* Age 18 years or older, who had ischemic stroke and 60 patients who had hemorrhagic stroke 6-18 months prior to their inclusion in the study.

Exclusion Criteria:

* Dynamic neurologic improvement or worsening during the last 4 weeks.
* Had been treated with HBO for any other reason prior to their inclusion.
* Have any other indication for HBOT
* Chest pathology incompatible with pressure changes
* Inner ear disease
* Patients suffering from claustrophobia.
* Inability to give written informed consent.
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: D