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Autistic DisorderPhase 1VPHNCT00670891

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

A Phase 1 study testing oxygen (Hyperbaric Oxygen Therapy) in people with Autistic Disorder, run by Vachira Phuket Hospital at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 9 years
Conditions the study is for
Autistic Disorder
What is being tested?
oxygen (Hyperbaric Oxygen Therapy)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteThailand
Study dates
Jul 2007to Apr 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 9 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Vachira Phuket Hospital

    Phuket, Phuket, 83000

Other trials in Thailand

About this study

Official title: A Prospective, Non-Randomized, Open-Label Study on the Clinical Effects of Hyperbaric Oxygen Therapy in Thai Autistic Children

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.

Read the detailed description

Detailed Description There is a general agreement that early identification of autistic spectrum disorders in children and intervention is extremely important.

We would like to find out beneficial effects for early identification and treatment in the autism. Another meaning, it declares that the autism is treatable and can be prevention in the early stage of the symptoms. According to many studies, they had shown brain injury could be caused by heavy metal effects, chemical poisoning, infection, autoimmune response, poor blood flow, lack of oxygen. There are many alternative therapies that were claimed to have some effects to make better results in autistic symptoms, but no definite one which could absolutely cured to the autism.

HBOT (Hyperbaric Oxygen Therapy) is a new way in the treatment for decompression sickness syndrome (Caisson disease) and it can be applied to intervene or concomitant treatments with some symptoms such as diabetic wounds, burnt wounds.

Vachira Phuket Hospital, HBOT center and child development center was established in 2002. This HBOT center is the only one stand-alone center of provincial hospitals in Thailand. Enthusiastic questions in our proceedings were how to declare our opportunities to be a center in HBOT and child developmental center.

If HBOT can be an effective method in alternative therapies, we can help our numerous autistic children. In our proceeding study we found that HBOT was the least interesting method of alternative therapies for the autism in parental opinions. (Figure 1.)

  1. General information, the most of sampling groups (75.68%) are female, 40.54% of aged-groups are 30-40 years old, 37.84% of occupations are employee and 32.43% of educations are primary school.
  2. Information about opinion of alternative therapies, the most of parents think that the music therapy is the best way. The second is Chiropractic and the third is Art therapy but Animal therapy with the pony is the least effective way.

In the topic of the knowledge about Alternative therapies, the most of parents know about Chiropractic, Art therapy and Music therapy as sequence. The parents know Hyperbaric Oxygen Therapy as the least.

They interested in Music therapy, Chiropractic and Art therapy as sequence. But they are interested in animal therapy with pony and dog as the least. The researchers think that the parents' knowledge about each therapy affects their decision making to choose for their children. Vachira Phuket Hospital has Hyperbaric oxygen therapy (Chamber) which is the new therapy for Autistic children but the parents don't have the knowledge about it. So, the researchers wonder how should we give the information to the parents in order to get the most benefit from this therapy.

Figure 1. Autistic parental attitude surveys in effective, knowledge and interesting in various therapies at Vachira Phuket Hospital, July 2007

Whatever it is our opportunities to prove how effective of HBOT in the treatment for autism and represent autistic pathology mechanisms in preceding hypotheses.

Advantages

  1. Administrator's support is provided.
  2. Equipment (HBOT) is in the same place with Development Training Clinic.
  3. Study by professional physicians in various associated experiences and the developmental nurse, psychologist who accustom with children and the parents (caretakers).
  4. Convenience in transportation, which is in a small province.
  5. This HBOT is solitary equipment, governed beneath Thailand Ministry of Public Health.

Disadvantages

  1. Publication in knowledge about HBOT is very low in Thailand.
  2. Harmful may be unknown hidden.
  3. Stigmatization is a delicate point in the parents of these children.
  4. Worrying and guilty feelings are easily occurred in the parents when something may be unexpected happening.
  5. A small province liked Phuket may be difficult to find volunteers for research or study's enrollment.
  6. Information gathering and assessment processes including scoring forms may be underneath standardization and not up-to-date.

Problems-solving plans

  1. Informed knowledge about HBOT, more and more, to the parents and community.
  2. Pre-treatment evaluation was carefully evaluated according to good clinical practice.
  3. Respected to their honour, patient's right and kept confidential of the volunteers.
  4. Reassured the parents and clarified in details of their concerned issues. Explained the strategies explicitly and slowly.
  5. Therefore studied in a small group, closed observation was applied to integrated in details for descriptive study in the volunteers.
  6. It could be a pilot study if their any parts of this study were not clearly understood. And thereafter, study planning in the future will be done in the advance conforming design and methodology following our knowledgeable experiences.
Being tested
oxygen (Hyperbaric Oxygen Therapy)
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • oxygen (Hyperbaric Oxygen Therapy)Procedure or surgery

    Also called HBOT

    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
Study groups in NCT00670891
Study groupRoleWhat they receive
HBOTExperimentalHBOT
Receives: Procedure: oxygen (Hyperbaric Oxygen Therapy)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Developmental and Skill training assessment, Rajanukul Hospital 5th edition

    Measured: 10 sessions assessment

Secondary outcomes (1)
  1. Developmental and Skill training assessment, Rajanukul Hospital 5th edition

    Measured: 20 sessions assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2008 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00670891
Sponsor's protocol ID
VP 000001
Acronym
VPH
Status last verified
Apr 2008
First submitted
29 Apr 2008
Last updated
29 May 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing oxygen (Hyperbaric Oxygen Therapy) in people with Autistic Disorder, run by Vachira Phuket Hospital at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Developmental and Skill training assessment, Rajanukul Hospital 5th edition (time frame: 10 sessions assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2008.

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