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

• ClinicalTrials.gov Identifier: NCT00335790
• Recruitment Status: Completed
• First Posted: June 12, 2006
• Last Update Posted: April 10, 2007
• Sponsor: International Hyperbarics Association
• Information provided by: International Hyperbarics Association

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autism	Procedure: Hyperbaric Therapy	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Double-Blind, Controlled Study on the Clinical Effects of Hyperbaric Therapy in Autistic Children
• Study Start Date: June 2006
• Actual Study Completion Date: March 2007

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Blinded Therapist Autism Diagnostic Observation Schedule (ADOS)
2. Blinded Therapist Aberrant Behavior Checklist (ABC-C)
3. Blinded Physician Clinical Global Impression Severity Score (CGI)
4. Parental Autism Treatment Evaluation Checklist (ATEC)

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 7 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Arizona

Center for Autism Research and Education

Phoenix, Arizona, United States, 85012

United States, Florida

International Child Development Resource Center

Melbourne, Florida, United States, 32901

United States, Virginia

Blue Ridge Spectrum Center

Charlottesville, Virginia, United States, 22901

Advocates for Children

Lynchburg, Virginia, United States, 24501

Sponsors and Collaborators

International Hyperbarics Association

Investigators

• Principal Investigator: Daniel A Rossignol, MD; University of Virginia

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• ClinicalTrials.gov Identifier: NCT00335790
• Other Study ID Numbers: HBA-2
• First Posted: June 12, 2006
• Last Update Posted: April 10, 2007
• Last Verified: April 2007

Additional relevant MeSH terms:

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