A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children

NCT00335790 | Completed

• 1 other identifier: HBA-2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

Autism is a neurodevelopmental disorder currently affecting 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 gastrointestinal and brain inflammation, increased markers of oxidative stress, and a relative mitochondrial dysfunction. Hyperbaric oxygen therapy (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 increases the production of mitochondria and 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. Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic children. We recently completed a prospective pilot trial using HBOT in 18 children which demonstrated significant clinical improvements in autistic children on several standardized scales. Most of the scales were parent-rated, although some were rated by teachers. However, parents were not blinded to the fact that their children received HBOT and evaluation of the children was through parent-rated scales, either of which could lead to bias. There was no placebo or control group. Therefore, the improvements found in this prospective study could have been due merely to chance or the natural development of the children. To determine if HBOT improves symptoms in autistic children, a double-blind controlled study is needed.

Conditions

Autism

Outcome Measures

Primary Outcomes (4)

• Blinded Therapist Autism Diagnostic Observation Schedule (ADOS)

• Blinded Therapist Aberrant Behavior Checklist (ABC-C)

• Blinded Physician Clinical Global Impression Severity Score (CGI)

• Parental Autism Treatment Evaluation Checklist (ATEC)

Interventions

Hyperbaric Therapy PROCEDURE

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• DSM-IV diagnosis of Autistic Disorder, confirmed with Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R)
• HBOT naïve

You may not qualify if:

• DSM-IV diagnosis of Pervasive Developmental Disorder other than Autistic Disorder including PDD-NOS (Pervasive Developmental Disorder, not otherwise specified) and Asperger's Syndrome
• Uncontrolled seizures
• Ear infection
• Uncontrolled asthma
• Inability to equalize ear pressure
• Fragile X syndrome
• Current therapy consisting of chelation

Sponsors & Collaborators

• International Hyperbarics Association: lead

Study Sites (4)

Center for Autism Research and Education

Phoenix, Arizona, 85012, United States

Location

International Child Development Resource Center

Melbourne, Florida, 32901, United States

Location

Blue Ridge Spectrum Center

Charlottesville, Virginia, 22901, United States

Location

Advocates for Children

Lynchburg, Virginia, 24501, United States

Location

Related Publications (1)

• Rossignol DA, Rossignol LW, Smith S, Schneider C, Logerquist S, Usman A, Neubrander J, Madren EM, Hintz G, Grushkin B, Mumper EA. Hyperbaric treatment for children with autism: a multicenter, randomized, double-blind, controlled trial. BMC Pediatr. 2009 Mar 13;9:21. doi: 10.1186/1471-2431-9-21.

  PMID: 19284641 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Daniel A Rossignol, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2006
• First Posted: June 12, 2006
• Study Start: June 1, 2006
• Study Completion: March 1, 2007
• Last Updated: April 10, 2007

Record last verified: 2007-04

Locations

US (4)