AutismNCT00324909
Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study
A study testing Hyperbaric Oxygen Therapy in people with Autism and Oxidative Stress, run by International Hyperbarics Association at 1 site in United States.
Trial summary
Autism is a neurodevelopmental disorder that currently affects as many as 1 out of 166 children in the United States. Autism is considered by many to be a permanent condition with little hope for improvement. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Autism, Oxidative Stress, Inflammation
- What is being tested?
- Hyperbaric Oxygen Therapy
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 2 to 18 years
- All sexes
- Child, Adult
Who may be able to join
- Children diagnosed with autism spectrum disorder
Who cannot join
- Seizures not controlled by medicine
- Inability to ventilate ears
Trial locations and contacts
1 site in 1 country.
United States1 site
Blue Ridge Medical Center
Arrington, Virginia, 22922
About this study
Official title: Effects of Hyperbaric Oxygen Therapy on Clinical Symptoms and Markers of Inflammation and Oxidative Stress in Autistic Children: A Pilot Study
Autism is a neurodevelopmental disorder that currently affects as many as 1 out of 166 children in the United States. Autism is considered by many to be a permanent condition with little hope for improvement. Treatment for autism is centered on special schooling and behavioral therapy; medical science currently has little to offer.
Recent research has discovered that some autistic individuals have decreased blood flow to the brain, evidence of inflammation in the brain, and increased markers of oxidative stress. Multiple independent single photon emission computed tomography (SPECT) and positron emission tomography (PET) research studies have revealed hypoperfusion to several areas of the autistic brain, most notably the temporal regions and areas specifically related to language comprehension and auditory processing. Several studies show that diminished blood flow to these areas correlates with many of the clinical features associated with autism including repetitive, self-stimulatory and stereotypical behaviors, and impairments in communication, sensory perception, and social interaction. Hyperbaric oxygen therapy (HBOT) has been used with clinical success in several cerebral hypoperfusion syndromes including cerebral palsy, fetal alcohol syndrome, closed head injury, and stroke. HBOT can compensate for decreased blood flow by increasing the oxygen content of plasma and body tissues and can even normalize oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT has potent anti-inflammatory effects and reduces oxidative stress. Furthermore, recent evidence demonstrates that HBOT mobilizes stem cells from human bone marrow which may aid recovery in neurodegenerative diseases. Based upon these findings, it is hypothesized that HBOT will improve symptoms in autistic individuals.
The purpose of this study is to determine if HBOT improves clinical outcomes in children with autism. The study will also determine if HBOT changes markers of inflammation and oxidative stress in autistic children.
- Conditions
- Autism, Oxidative Stress, Inflammation
- Being tested
- Hyperbaric Oxygen Therapy
- Medical subject headings
- Autistic Disorder, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on autism rating scales before and after HBOT
Measure of inflammation before and after HBOT
Measures of oxidative stress before and after HBOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants
Sponsor and investigators
- Lead sponsor
- International Hyperbarics Association
- Sponsor type
- University, hospital or other
- Investigators
- Daniel A Rossignol, MD, Principal investigator, Blue Ridge Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324909
- Sponsor's protocol ID
- HBA-1
- Status last verified
- Apr 2007
- First submitted
- 9 May 2006
- Last updated
- 10 Apr 2007
- Results posted
- No
Publications
Rossignol DA, Rossignol LW, James SJ, Melnyk S, Mumper E. The effects of hyperbaric oxygen therapy on oxidative stress, inflammation, and symptoms in children with autism: an open-label pilot study. BMC Pediatr. 2007 Nov 16;7:36. doi: 10.1186/1471-2431-7-36.
PubMed 18005455
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyperbaric Oxygen Therapy on Clinical Symptoms and Markers of Inflammation and Oxidative Stress in Autistic Children: A Pilot Study
- ClinicalTrials.gov ID
- NCT00324909
- Acronym / sponsor ID
- HBA-1
- Conditions
- Autism, Oxidative Stress, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants
- Lead sponsor
- International Hyperbarics AssociationUniversity, hospital or other
- First posted
- 11 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autism is a neurodevelopmental disorder that currently affects as many as 1 out of 166 children in the United States. Autism is considered by many to be a permanent condition with little hope for improvement. Treatment for autism is centered on special schooling and behavioral therapy; medical science currently has little to offer.
Recent research has discovered that some autistic individuals have decreased blood flow to the brain, evidence of inflammation in the brain, and increased markers of oxidative stress. Multiple independent single photon emission computed tomography (SPECT) and positron emission tomography (PET) research studies have revealed hypoperfusion to several areas of the autistic brain, most notably the temporal regions and areas specifically related to language comprehension and auditory processing. Several studies show that diminished blood flow to these areas correlates with many of the clinical features associated with autism including repetitive, self-stimulatory and stereotypical behaviors, and impairments in communication, sensory perception, and social interaction. Hyperbaric oxygen therapy (HBOT) has been used with clinical success in several cerebral hypoperfusion syndromes including cerebral palsy, fetal alcohol syndrome, closed head injury, and stroke. HBOT can compensate for decreased blood flow by increasing the oxygen content of plasma and body tissues and can even normalize oxygen levels in ischemic tissue. In addition, animal studies have shown that HBOT has potent anti-inflammatory effects and reduces oxidative stress. Furthermore, recent evidence demonstrates that HBOT mobilizes stem cells from human bone marrow which may aid recovery in neurodegenerative diseases. Based upon these findings, it is hypothesized that HBOT will improve symptoms in autistic individuals.
The purpose of this study is to determine if HBOT improves clinical outcomes in children with autism. The study will also determine if HBOT changes markers of inflammation and oxidative stress in autistic children.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children diagnosed with autism spectrum disorder
Key exclusion criteria (2 listed)
- Seizures not controlled by medicine
- Inability to ventilate ears
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy | Drug | – |
Primary outcome
Scores on autism rating scales before and after HBOT
Measure of inflammation before and after HBOT
Measures of oxidative stress before and after HBOT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2007.
- Derived from this study: PubMed 18005455Rossignol DA, Rossignol LW, James SJ, Melnyk S, Mumper E. The effects of hyperbaric oxygen therapy on oxidative stress, inflammation, and symptoms in children with autism: an open-label pilot study. BMC Pediatr. 2007 Nov 16;7:36. doi: 10.1186/1471-2431-7-36.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel A Rossignol, MD principal investigator
Blue Ridge Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Autism and Oxidative Stress, run by International Hyperbarics Association at 1 site in United States.
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 1 inclusion and 2 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 10 Apr 2007. 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 United States. 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.
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?
Scores on autism rating scales before and after HBOT. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00324909, which also lists 1 linked publication.
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 10 Apr 2007.