Effects of Hyperbaric Oxygen Therapy on Children With Autism

This study has been completed.
Sponsor:
Information provided by:
Thoughtful House
ClinicalTrials.gov Identifier:
NCT00406159
First received: November 29, 2006
Last updated: August 6, 2009
Last verified: August 2009
  Purpose

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. Hyperbaric Oxygenation Therapy will be safe to use with children with autism.
  2. Hyperbaric Oxygenation Therapy will have a statistically significant effect on the symptoms of autism.
  3. Hyperbaric Oxygenation Therapy will have a clinically significant observable effect on the overt symptoms of autism.
  4. The decreases in the symptoms of autism will correlate positively with the number of Hyperbaric Oxygenation Therapy sessions.
  5. Treatment gains obtained from Hyperbaric Oxygenation Therapy will be maintained at follow-up, post 40 treatment sessions.

SPECIFIC AIMS

  1. Provide further evidence for the safety of Hyperbaric Oxygenation Therapy in children with autism.
  2. To quantitatively assess the effects of Hyperbaric Oxygenation Therapy on behavioral and cognitive symptoms of autism before, during, and after treatment.
  3. Identify number of treatments required to reach therapeutic effects.
  4. Identify the length and durability of treatment effect and maintenance.

Condition Intervention Phase
Autism
Device: Hyperbaric Oxygen Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Hyperbaric Oxygen Therapy on Behavioral Measures of Short Term Memory, Learning, and Behavior in Children With Autism

Resource links provided by NLM:


Further study details as provided by Thoughtful House:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: November 2006
Study Completion Date: September 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406159

Locations
United States, Texas
Medical Center at Thoughtful House
Austin, Texas, United States, 78746
Sponsors and Collaborators
Thoughtful House
Investigators
Study Director: Andrew Wakefield, MD Thoughtful House Center for Children
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00406159     History of Changes
Other Study ID Numbers: 06.10.0004
Study First Received: November 29, 2006
Last Updated: August 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Thoughtful House:
Autism
Hyperbaric Oxygen Therapy
Behavioral assessments

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014