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

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ClinicalTrials.gov Identifier: NCT00670891
Recruitment Status : Completed
First Posted : May 2, 2008
Last Update Posted : May 29, 2008
Sponsor:
Information provided by:
Vachira Phuket Hospital

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Autistic Disorder Procedure: oxygen (Hyperbaric Oxygen Therapy) Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Developmental and Skill training assessment, Rajanukul Hospital 5th edition [ Time Frame: 10 sessions assessment ]

Secondary Outcome Measures :
  1. Developmental and Skill training assessment, Rajanukul Hospital 5th edition [ Time Frame: 20 sessions assessment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670891


Locations
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Thailand
Vachira Phuket Hospital
Phuket, Thailand, 83000
Sponsors and Collaborators
Vachira Phuket Hospital
Investigators
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Principal Investigator: Jessada Chungpaibulpatana, MD. Vachira Phuket Hospital
More Information
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Responsible Party: HBOT and Developmental Clinic Team, Vachira Phuket Hospital
ClinicalTrials.gov Identifier: NCT00670891     History of Changes
Other Study ID Numbers: VP 000001
First Posted: May 2, 2008    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: April 2008

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