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

Primary Purpose

Autism, Oxidative Stress, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Sponsored by
International Hyperbarics Association
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All Sexes

Inclusion Criteria: Children diagnosed with autism spectrum disorder Exclusion Criteria: Seizures not controlled by medicine Inability to ventilate ears

Sites / Locations

  • Blue Ridge Medical Center

Outcomes

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2006
Last Updated
April 9, 2007
Sponsor
International Hyperbarics Association
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1. Study Identification

Unique Protocol Identification Number
NCT00324909
Brief Title
Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study
Official Title
Effects of Hyperbaric Oxygen Therapy on Clinical Symptoms and Markers of Inflammation and Oxidative Stress in Autistic Children: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
International Hyperbarics Association

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Oxidative Stress, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Hyperbaric Oxygen Therapy
Primary Outcome Measure Information:
Title
Scores on autism rating scales before and after HBOT
Title
Measure of inflammation before and after HBOT
Title
Measures of oxidative stress before and after HBOT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Children diagnosed with autism spectrum disorder Exclusion Criteria: Seizures not controlled by medicine Inability to ventilate ears
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A Rossignol, MD
Organizational Affiliation
Blue Ridge Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blue Ridge Medical Center
City
Arrington
State/Province
Virginia
ZIP/Postal Code
22922
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18005455
Citation
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. doi: 10.1186/1471-2431-7-36.
Results Reference
derived

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

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