Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study - Full Text View

Sponsored by:	International Hyperbarics Association
Information provided by:	International Hyperbarics Association
ClinicalTrials.gov Identifier:	NCT00324909

Purpose

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	Intervention
Autism Oxidative Stress Inflammation	Drug: Hyperbaric Oxygen Therapy

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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 NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by International Hyperbarics Association:

Primary Outcome Measures:

Scores on autism rating scales before and after HBOT
Measure of inflammation before and after HBOT
Measures of oxidative stress before and after HBOT

Estimated Enrollment:

18

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Children diagnosed with autism spectrum disorder

Exclusion Criteria:

Seizures not controlled by medicine
Inability to ventilate ears

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by International Hyperbarics Association

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Rossignol DA, Rossignol LW, James SJ, Melnyk S, Mumper E. The effects of hyperbaric oxygen therapy on oxidative stress, inflammation, and symptoms in children with autism: an open-label pilot study. BMC Pediatr. 2007 Nov 16;7:36.

Study ID Numbers:	HBA-1
Study First Received:	May 9, 2006
Last Updated:	April 9, 2007
ClinicalTrials.gov Identifier:	NCT00324909 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autistic Disorder
Stress
Autism
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Stress
Inflammation

ClinicalTrials.gov processed this record on September 01, 2009