Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00335790
Status:
COMPLETED
Last Update Posted:
2007-04-10
First Post:
2006-06-09
Brief Title:
A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children
Sponsor:
International Hyperbarics Association
Organization:
International Hyperbarics Association
Study Overview
Official Title:
A Prospective Randomized Double-Blind Controlled Study on the Clinical Effects of Hyperbaric Therapy in Autistic Children
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Autism is a neurodevelopmental disorder currently affecting 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 gastrointestinal and brain inflammation increased markers of oxidative stress and a relative mitochondrial dysfunction Hyperbaric oxygen therapy 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 increases the production of mitochondria and 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
Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic children We recently completed a prospective pilot trial using HBOT in 18 children which demonstrated significant clinical improvements in autistic children on several standardized scales Most of the scales were parent-rated although some were rated by teachers However parents were not blinded to the fact that their children received HBOT and evaluation of the children was through parent-rated scales either of which could lead to bias There was no placebo or control group Therefore the improvements found in this prospective study could have been due merely to chance or the natural development of the children To determine if HBOT improves symptoms in autistic children a double-blind controlled study is needed
Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic children We recently completed a prospective pilot trial using HBOT in 18 children which demonstrated significant clinical improvements in autistic children on several standardized scales Most of the scales were parent-rated although some were rated by teachers However parents were not blinded to the fact that their children received HBOT and evaluation of the children was through parent-rated scales either of which could lead to bias There was no placebo or control group Therefore the improvements found in this prospective study could have been due merely to chance or the natural development of the children To determine if HBOT improves symptoms in autistic children a double-blind controlled study is needed
Detailed Description:
Autism is a neurodevelopmental disorder currently affecting as many as 1 out of 166 children in the United States Autism is considered by many to be a permanent static 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 cerebral perfusion evidence of gastrointestinal and neuro-inflammation increased markers of oxidative stress and a relative mitochondrial dysfunction 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 increases the production of mitochondria and 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
Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic children We recently completed a prospective pilot trial using HBOT in 18 children which demonstrated statistically significant clinical improvements in autistic children on several standardized scales Most of the scales were parent-rated although some were rated by teachers However parents were not blinded to the fact that their children received HBOT and evaluation of the children was through parent-rated scales either of which could lead to bias There was no placebo or control group Therefore the improvements found in this prospective study could have been due merely to chance or the natural development of the children To determine if HBOT improves symptoms in autistic children a double-blind controlled study is indicated
Our recent retrospective case series demonstrated that HBOT may improve symptoms in autistic children We recently completed a prospective pilot trial using HBOT in 18 children which demonstrated statistically significant clinical improvements in autistic children on several standardized scales Most of the scales were parent-rated although some were rated by teachers However parents were not blinded to the fact that their children received HBOT and evaluation of the children was through parent-rated scales either of which could lead to bias There was no placebo or control group Therefore the improvements found in this prospective study could have been due merely to chance or the natural development of the children To determine if HBOT improves symptoms in autistic children a double-blind controlled study is indicated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None