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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00335790
First Posted: June 12, 2006
Last Update Posted: April 10, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
International Hyperbarics Association
June 9, 2006
June 12, 2006
April 10, 2007
June 2006
Not Provided
  • 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)
Same as current
Complete list of historical versions of study NCT00335790 on ClinicalTrials.gov Archive Site
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A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children
A Prospective, Randomized, Double-Blind, Controlled Study on the Clinical Effects of Hyperbaric Therapy in Autistic Children

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.

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, static 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 cerebral perfusion, evidence of gastrointestinal and neuro-inflammation, increased markers of oxidative stress, and a relative mitochondrial dysfunction. 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 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 statistically 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 indicated.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Autism
Procedure: Hyperbaric Therapy
Not Provided
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. Erratum in: BMC Pediatr. 2012 Dec;42(4):236.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2007
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
2 Years to 7 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00335790
HBA-2
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International Hyperbarics Association
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Principal Investigator: Daniel A Rossignol, MD University of Virginia
International Hyperbarics Association
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP