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Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study

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ClinicalTrials.gov Identifier: NCT00324909
Recruitment Status : Completed
First Posted : May 11, 2006
Last Update Posted : April 10, 2007
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Autism Oxidative Stress Inflammation Drug: Hyperbaric Oxygen Therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Hyperbaric Oxygen Therapy on Clinical Symptoms and Markers of Inflammation and Oxidative Stress in Autistic Children: A Pilot Study

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Scores on autism rating scales before and after HBOT
  2. Measure of inflammation before and after HBOT
  3. Measures of oxidative stress before and after HBOT

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Children diagnosed with autism spectrum disorder

Exclusion Criteria:

  • Seizures not controlled by medicine
  • Inability to ventilate ears
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324909


Locations
United States, Virginia
Blue Ridge Medical Center
Arrington, Virginia, United States, 22922
Sponsors and Collaborators
International Hyperbarics Association
Investigators
Principal Investigator: Daniel A Rossignol, MD Blue Ridge Medical Center
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00324909     History of Changes
Other Study ID Numbers: HBA-1
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: April 10, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Inflammation
Pathologic Processes