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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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; Air or Gas Embolus; Decompression Illness; Carbon Monoxide poising; Clostridial Myonecrosis (Gas Gangrene); Necrotizing Fasciitis; Crush Injury (Compartment syndromes); Selected Problem Wounds; Compromised Skin Flaps or Grafts; Refractory Osteomyelitis; Exceptional Anemia due to Blood loss; Osteoradionecrosis; Thermal Burns and Radiation Tissue Damage; Diabetic Wounds; Intra-Cranial Abscess; Brain Injury and other Head Trauma; Cerebral Palsy; High Altitude Sickness; Lyme disease; Other Name: HBOT

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted:	May 2, 2008
Last Update Posted:	May 29, 2008
Last Verified:	April 2008

Additional relevant MeSH terms:

Autistic Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders