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Clinical Trials/NCT00324909
NCT00324909
Completed
Not Applicable

Effects of Hyperbaric Oxygen Therapy on Clinical Symptoms and Markers of Inflammation and Oxidative Stress in Autistic Children: A Pilot Study

International Hyperbarics Association1 site in 1 country18 target enrollmentMay 11, 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
International Hyperbarics Association
Enrollment
18
Locations
1
Primary Endpoint
Scores on autism rating scales before and after HBOT
Status
Completed
Last Updated
19 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2006
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
International Hyperbarics Association

Eligibility Criteria

Inclusion Criteria

  • Children diagnosed with autism spectrum disorder

Exclusion Criteria

  • Seizures not controlled by medicine
  • Inability to ventilate ears

Outcomes

Primary Outcomes

Scores on autism rating scales before and after HBOT

Measure of inflammation before and after HBOT

Measures of oxidative stress before and after HBOT

Study Sites (1)

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