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A Clinical Trial of the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children (VPH)

This study has been completed.
Sponsor:
Information provided by:
Vachira Phuket Hospital
ClinicalTrials.gov Identifier:
NCT00670891
First received: April 29, 2008
Last updated: May 26, 2008
Last verified: April 2008
History of Changes
  Purpose

Autism is a developmental and behavioral pattern which includes the triad of impairments, 1. social interaction 2. social communication 3. imagination. Inevitable difficulties in the treatment, managing and handle with autistic children are the main problems. Their memories are seemingly in picture or photo records, which are difference from normal population. There are many concepts but no concise in causative factors, including useful treatments, useless and prolong remaining in many studies.

HBOT (Hyperbaric Oxygen Therapy) is a quite modern treatment in Thailand for nitrogen imbalance (decompression sickness syndrome or Caisson disease). How can we apply it to treat the autism? A hypothesis shows evidence that neurons surrounding the permanently damaged epicenter of injury can be reactivated with increased oxygen. Oxygen exists in the blood in two forms, combined with hemoglobin and dissolved in plasma. More oxygen is transported by hemoglobin, but oxygen is delivered to the tissues in dissolved form by the liquid portion of blood. HBOT can increase in plasma oxygen to the tissues including the brain. A little change in oxygen can make the better improvements in : cognitive ability, socialization, sleep, calmness, decreased stimming and language. It can make increased in Glutathione (GSH), and Glutathione (GSH) can decreased in oxidative stress with effected to remove metal compounds (mercury) to improve the autism.

This clinical trial study divided into 3 group populations 1. general autism 2. post-treatment chiropractic autism 3. medicated autism. This comparative study shows the major clinical symptoms before and after the treatment with HBOT. This study results and analysis are the most important for our further projects planning.


Condition Intervention Phase
Autistic Disorder
 Procedure: oxygen (Hyperbaric Oxygen Therapy)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Non-Randomized, Open-Label Study on the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Further study details as provided by Vachira Phuket Hospital:

Primary Outcome Measures:
  • Developmental and Skill training assessment, Rajanukul Hospital 5th edition [ Time Frame: 10 sessions assessment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Developmental and Skill training assessment, Rajanukul Hospital 5th edition [ Time Frame: 20 sessions assessment ] [ Designated as safety issue: Yes ]
Enrollment: 7
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HBOT
HBOT
 Procedure: oxygen (Hyperbaric Oxygen Therapy)

Current Accepted Applications of HBOT (2008) Jan 2003, ANDI International

  1. Air or Gas Embolus
  2. Decompression Illness
  3. Carbon Monoxide poising
  4. Clostridial Myonecrosis (Gas Gangrene)
  5. Necrotizing Fasciitis
  6. Crush Injury (Compartment syndromes)
  7. Selected Problem Wounds
  8. Compromised Skin Flaps or Grafts
  9. Refractory Osteomyelitis
  10. Exceptional Anemia due to Blood loss
  11. Osteoradionecrosis
  12. Thermal Burns and Radiation Tissue Damage
  13. Diabetic Wounds
  14. Intra-Cranial Abscess
  15. Brain Injury and other Head Trauma
  16. Cerebral Palsy
  17. High Altitude Sickness
  18. Lyme disease
Other Name: HBOT

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   5 Years to 9 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Both sexes
  2. All aged-group
  3. All educated group
  4. Diagnosis - Autistic disorder, Autistic spectrums
  5. Major symptoms - delayed development, delayed speech

Exclusion criteria:

  1. Uncontrolled severe explosive behaviours
  2. Uncontrolled organic or physical symptoms such as seizure, ear infection
  3. Severe phobic or fearful symptoms
  4. No parent or caretaker
  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: NCT00670891

Locations
Thailand
Vachira Phuket Hospital
Phuket, Thailand, 83000
Sponsors and Collaborators
Vachira Phuket Hospital
Investigators
Principal Investigator: Jessada Chungpaibulpatana, MD. Vachira Phuket Hospital
  More Information

Responsible Party: HBOT and Developmental Clinic Team, Vachira Phuket Hospital
ClinicalTrials.gov Identifier: NCT00670891     History of Changes
Other Study ID Numbers: VP 000001 
Study First Received: April 29, 2008
Last Updated: May 26, 2008
Health Authority: Thailand: Ministry of Public Health

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016