Pilot Study of the Effect of Hyperbaric Oxygen Treatment on Behavioral and Biomarker Measures in Children With Autism

NCT00584480 | Completed Phase 3 Results DMC

• 1 other identifier: 200715202-1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to increase the understanding of the effect of Hyperbaric Oxygen Treatment (HBOT) on the behavior and functioning of children with autism. The main goal of this study is to demonstrate that HBOT is safe and tolerable in autistic children, and to measure the effect of HBOT on specific chemicals in their blood that may play a role in the child's behavior.

Conditions

Autism

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Given Clinical Global Impression Scale - Improvement (CGI-I) Score

  Assessment of global changes in severity of autistic symptoms. CGI-I scores formulated by the clinician based on parent interview of changes in the child's behavior and from direct clinical observation, where scores of 0 = no improvement,1 = minimally improved, 2 = much improved, and 3 = very much improved.

  Baseline, 8 Weeks from baseline, and 20 Weeks from baseline

Study Arms (1)

1

ACTIVE COMPARATOR

Active Hyperbaric Oxygen Treatment (HBOT)

Other: Hyperbaric Oxygen Treatment (HBOT)

Interventions

Hyperbaric Oxygen Treatment (HBOT) OTHER

1.5 ATA at 100% Oxygen of HBOT

1

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of DSM-IV defined autism and meets cut off for autism on the Autism Diagnostic Inventory-Revised (ADI-R) or Social Communication Questionnaire (SCQ) and the Autism Diagnostic Observation Scale (ADOS).
• Age 3 to 8 years.
• Nonverbal IQ of 50 or above.
• Parental agreement to continue present dietary, behavioral or psychotropic drug treatment but not change treatment during 20 week intervention.

You may not qualify if:

• Clinical evidence of seizure disorder
• Active infection with fever
• Fragile X or other known genetic cause of autism
• Perinatal brain injury (e.g. cerebral palsy)
• Previous adequate trial (at least 20 session) of HBOT
• Inability to clear ears in the HBOT chambers

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of California, Davis: collaborator

Related Publications (1)

• Bent S, Bertoglio K, Ashwood P, Nemeth E, Hendren RL. Brief report: Hyperbaric oxygen therapy (HBOT) in children with autism spectrum disorder: a clinical trial. J Autism Dev Disord. 2012 Jun;42(6):1127-32. doi: 10.1007/s10803-011-1337-3.

  PMID: 21818676 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

1\) Small sample size 2) Lack of control group prevented an examination of whether changes in clinical measure of disease severity were due to HBOT or other factors.

Results Point of Contact

• Title: Robert L. Hendren, D.O.
• Organization: UCSF

Robert.Hendren@ucsf.edu

415-476-7198

Study Officials

• Robert L Hendren, DO

  University of California, Davis - M.I.N.D. Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 2, 2008
• Study Start: October 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 7, 2012
• Results First Posted: April 13, 2012

Record last verified: 2012-08