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

Completed · Not applicable

Conditions studied: Autism

In brief

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.

Key facts

Study ID

NCT00335790

Run by

International Hyperbarics Association

People needed

60

Starts

2006-06-01

Expected to finish

2007-03-01

Last updated by the study team

2007-04-10

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Center for Autism Research and Education — Phoenix, Arizona, United States
• International Child Development Resource Center — Melbourne, Florida, United States
• Blue Ridge Spectrum Center — Charlottesville, Virginia, United States
• Advocates for Children — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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