Effects of Hyperbaric Oxygen Therapy on Children With Autism - Full Text View

Sponsor:	Thoughtful House
Information provided by:	Thoughtful House
ClinicalTrials.gov Identifier:	NCT00406159

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

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

SPECIFIC AIMS

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

Condition	Intervention	Phase
Autism	Device: Hyperbaric Oxygen Therapy	Phase I

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:

MedlinePlus related topics: Autism Oxygen Therapy

U.S. FDA Resources

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

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:

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

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

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.

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 February 09, 2012