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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00324909
• Other study ID #: HBA-1
• Status: Completed
• Phase: N/A
• First received: May 9, 2006
• Last updated: April 9, 2007

Study information

• Verified date: April 2007
• Source: International Hyperbarics Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children diagnosed with autism spectrum disorder

Exclusion Criteria:

• Seizures not controlled by medicine

• Inability to ventilate ears

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Inflammation
• Oxidative Stress

Intervention

Drug:
• Hyperbaric Oxygen Therapy

Locations

Country	Name	City	State
United States	Blue Ridge Medical Center	Arrington	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
International Hyperbarics Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on autism rating scales before and after HBOT
Primary	Measure of inflammation before and after HBOT
Primary	Measures of oxidative stress before and after HBOT