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Autism clinical trials

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NCT ID: NCT00352352 Completed - Autism Clinical Trials

Use of Acupuncture In Children With Autistic Spectrum Disorder

Start date: n/a
Phase: Phase 3
Study type: Interventional

This is a study of the efficacy of acupuncture in children with autism.

NCT ID: NCT00352248 Completed - Autism Clinical Trials

Randomized Controlled Trial of Acupuncture Versus Sham Acupuncture in Autistic Spectrum Disorder

Start date: n/a
Phase: Phase 3
Study type: Interventional

We aim to study the efficacy of Acupuncture versus sham acupuncture in children with ASD.

NCT ID: NCT00346736 Completed - Autism Clinical Trials

Use of Acupuncture In Children With Autistic Spectrum Disorder

Start date: May 2005
Phase: Phase 3
Study type: Interventional

Autism is a behaviorally defined, lifelong disorder of the brain, affecting at least 1-2 per 1000 children. There is an increasing trend of autism worldwide. However, to date, there is still no cure for this devastating childhood disease. Autism is characterized by deficit in language, social communication and repetitive behavior. It is estimated that the annual cost of care for autism is $13 billion in USA alone. Children with autism usually have associated behavioral problems such as aggressiveness, stereotypes, hyperactivity, emotional lability, and short attention span. The National Institute of Child Health & Human Development and National Institute of Deafness & Communication Disorders have jointly founded the Collaborative Programs of Excellence in Autism. One of the long-term NIH goals is to develop or refine interim treatment strategy and to develop effective biological, behavioral or alternative treatment strategy for autism. There is a dire need for early identification and treatment of children with autism. Acupuncture has been practised in China for 2 millennia. The legal status of acupuncture as a treatment technique was approved by Food & Drugs Administration in USA (1997). The therapeutic effect of acupuncture is based on stimulation at specific acupoints resulting in both local and distant effect via improving signal or modulation of electromagnetic energy. There had lack of studies of acupuncture in autism. We hope that we can study the efficacy of acupuncture in autism using clinical measurement. We hope to identify the role of acupuncture as an adjunctive treatment for autism.

NCT ID: NCT00335790 Completed - Autism Clinical Trials

A Controlled Trial of the Clinical Effects of Hyperbaric Therapy in Autistic Children

Start date: June 2006
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00325572 Terminated - Autism Clinical Trials

Evaluation and Treatment of Copper/Zinc Imbalance in Children With Autism

Start date: November 2006
Phase: Phase 1
Study type: Interventional

There are two phases to the study. The first will examine serum copper and zinc levels and copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same sex and age children who are developing typically. The hypothesis is that there is a significant difference in the copper/zinc ratio between young children who have autism and their typically developing peers. The second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin C for 16 weeks on selected symptoms of autism. Children with autism will be enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be statistically higher than typically developing children. Measurements of serum copper, zinc and unbound copper will be obtained prior to, at the mid-point and end of the trial. Those children whose ratios have not fallen below 1.25, the top of the currently recognized range will have the zinc and vitamin C doses adjusted for the duration of the trial. Detailed evaluation of language skills, and a variety of behaviors will be evaluated prior to and after supplementation. The study will be placebo-controlled and double blind. Those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study. The hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin C and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism.

NCT ID: NCT00324909 Completed - Inflammation Clinical Trials

Effects of Hyperbaric Oxygen Therapy in Autistic Children: A Pilot Study

Start date: n/a
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT00319722 Recruiting - Autism Clinical Trials

EEG Studies of Sensory Processing in Autistic Children

Start date: February 2006
Phase: Phase 1
Study type: Observational

This study uses EEG to study brain waves at rest and in response to specific auditory and visual sensory stimuli in autistic children. We hypothesize that, compared to same age peers, autistics will show abnormalities in their electrophysiologic processing of sounds (tones and phonemes)and visual stimuli (flashes of light)and that these abnormalities will be able to separate autistics not only from typical children but also into clinical subgroups with specific biological/electrophysiological characteristics. We hope to find biological measures which will prove diagnostic of autism in very young children and which can be used in the measurement of treatment outcome in future intervention trials.

NCT ID: NCT00308074 Completed - Autism Clinical Trials

An Open-Label Trial of Aripiprazole in Autism Spectrum Disorders

Start date: February 2006
Phase: Phase 2
Study type: Interventional

The aim of this study is to evaluate the efficacy, safety and tolerability of aripiprazole monotherapy in the treatment of children and adolescents suffering from ASD over a 12-week period. We hypothesize that aripiprazole may be helpful in reducing ASD-associated symptoms of anxiety and aggression, resulting in significant improvements in global outcome.

NCT ID: NCT00277407 Completed - Autism Clinical Trials

Treatment of Autistic Children Using NAET Procedures

Start date: June 2006
Phase: N/A
Study type: Interventional

1. Purpose of this study is to determine whether NAET procedures are effective in the treatment of children with allergy-related autism spectrum disorders in restoring their verbal and nonverbal communication. 2. Hypothesis: Children in the experimental group will show a significant improvement over the control group in verbal and nonverbal communication as most food allergen groups, environmental allergen groups, childhood immunizations, and some other relevant allergenic substances are desensitized in a systematic way using NAET® procedures within the specified period of study.

NCT ID: NCT00271622 Recruiting - Autism Clinical Trials

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Start date: February 27, 2006
Phase:
Study type: Observational

The purpose of this protocol is to allow for the careful evaluation of healthy volunteers and individuals with risk for psychiatric disorders or neurodevelopmental disorders, such as autism spectrum disorder for specific protocols at NIH.