Effects of Hyperbaric Oxygen Therapy on Children With Autism

NCT00406159 | Completed Phase 1

• 1 other identifier: 06.10.0004
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE The purpose of this investigation is to evaluate the cognitive and behavioral effects of Hyperbaric Oxygenation Therapy in children who present with a diagnosis of autism spectrum disorder. HYPOTHESIS

1. 1.Hyperbaric Oxygenation Therapy will be safe to use with children with autism.
2. 2.Hyperbaric Oxygenation Therapy will have a statistically significant effect on the symptoms of autism.
3. 3.Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on the overt symptoms of autism.
4. 4.The decreases in the symptoms of autism will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
5. 5.Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.
6. 6.Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children with autism.
7. 7.To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment.
8. 8.Identify number of treatments required to reach therapeutic effects.
9. 9.Identify the length and durability of treatment effect and maintenance.

Conditions

Autism

Keywords

Autism; Hyperbaric Oxygen Therapy; Behavioral assessments

Outcome Measures

Primary Outcomes (15)

• Standardized Measures

• In addition to the direct measures of behavior described above, standardized intelligence and adaptive assessments will be conducted prior to the initiation of HBOT. These will include:

• ADI/ADOS

• WPPSI-III (2-6 years) /WASI (6+ years)

• Vineland Adaptive Behavior Scale (VABS)

• Subjective Questionnaires

• Aberrant Behavior Checklist

• Clinical Global Impression

• ATEC

• Selected sections of the APEQ

• BRIEF

• Parenting Stress Index

• Repetitive Behavior Scale

• A side effect questionnaire

• Thoughtful House Caregiver diary

Interventions

Hyperbaric Oxygen Therapy DEVICE

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children 2-10 years diagnosed with autism, PDD, or Aspergers
• No anticipated changes in treatment for the study duration (e.g., diet, nutrients)
• No additional biomedical treatments started 6 weeks prior to enrollment
• No changes in dietary management for 3 months prior to enrollment
• Access to Thoughtful House on a daily basis, or as necessary for the study participation
• In addition, the child participant must be:
• Ambulatory or require minimum support walking, per parent
• Able to sit still for 5 minutes or longer with a preferred toy item, per parent
• Adequate vision and hearing for the purposes of test administration, per parent
• Adequate arm-hand-finger coordination (i.e., able to point) for learning and cognitive tasks used in outcome measurement, per parent
• Stable and controlled medical disorder
• Under the care of a caregiver willing to participate by attending regularly scheduled appointments and completing the necessary measures

Sponsors & Collaborators

• Thoughtful House: lead

Study Sites (1)

Medical Center at Thoughtful House

Austin, Texas, 78746, United States

Location

Related Publications (2)

• Rossignol DA, Rossignol LW. Hyperbaric oxygen therapy may improve symptoms in autistic children. Med Hypotheses. 2006;67(2):216-28. doi: 10.1016/j.mehy.2006.02.009. Epub 2006 Mar 22.

  PMID: 16554123 RESULT

• Jepson B, Granpeesheh D, Tarbox J, Olive ML, Stott C, Braud S, Yoo JH, Wakefield A, Allen MS. Controlled evaluation of the effects of hyperbaric oxygen therapy on the behavior of 16 children with autism spectrum disorders. J Autism Dev Disord. 2011 May;41(5):575-88. doi: 10.1007/s10803-010-1075-y.

  PMID: 20680427 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

• Andrew Wakefield, MD

  Thoughtful House Center for Children

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 29, 2006
• First Posted: December 4, 2006
• Study Start: November 1, 2006
• Study Completion: September 1, 2007
• Last Updated: August 7, 2009

Record last verified: 2009-08

Locations

US (1)