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

NCT00670891 | Completed Phase 1 DMC

• 1 other identifier: VP 000001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Autistic Disorder

Outcome Measures

Primary Outcomes (1)

• Developmental and Skill training assessment, Rajanukul Hospital 5th edition

  10 sessions assessment

Secondary Outcomes (1)

• Developmental and Skill training assessment, Rajanukul Hospital 5th edition

  20 sessions assessment

Study Arms (1)

HBOT

EXPERIMENTAL

HBOT

Procedure: oxygen (Hyperbaric Oxygen Therapy)

Interventions

oxygen (Hyperbaric Oxygen Therapy) PROCEDURE

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

Also known as: HBOT

HBOT

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Both sexes
• All aged-group
• All educated group
• Diagnosis - Autistic disorder, Autistic spectrums
• Major symptoms - delayed development, delayed speech

You may not qualify if:

• Uncontrolled severe explosive behaviours
• Uncontrolled organic or physical symptoms such as seizure, ear infection
• Severe phobic or fearful symptoms
• No parent or caretaker

Sponsors & Collaborators

• Vachira Phuket Hospital: lead

Study Sites (1)

Vachira Phuket Hospital

Phuket, Phuket, 83000, Thailand

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Jessada Chungpaibulpatana, MD.

  Vachira Phuket Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 2, 2008
• Study Start: July 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: May 29, 2008

Record last verified: 2008-04

Locations

TH (1)