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Autism clinical trials

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NCT ID: NCT01983189 Terminated - Autism Clinical Trials

Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism

Start date: November 2008
Phase: Phase 2
Study type: Interventional

This study is a trial of low frequency Repetitive Transcranial magnetic stimulation( rTMS) for subjects with autism spectrum disorders, specially targeting repetitive behaviors.

NCT ID: NCT01730079 Terminated - Clinical trials for Attention Deficit Hyperactivity Disorder

Near Infrared Spectroscopy in Children With Autism and ADHD

Start date: October 23, 2012
Phase:
Study type: Observational

Background: - Near-infrared spectroscopy (NIRS) is a functional imaging technique that can be uses light to study brain function while allowing for movement. To look at blood flow in the brain, NIRS uses a low-power light source with detectors that see how the light changes as it passes through brain tissue. Brain blood flow can indicate which parts of the brain are active during different tasks. Researchers want to study children with attention deficit hyperactivity disorder (ADHD) and autism spectrum disorders (ASD) and will use NIRS to compare the blood flow in the brain of children with ADHD and ASD with that of typically developing children. Objectives: - To see how well NIRS can detect changes in brain blood flow during tests of thinking and memory in children. - To compare blood flow in the brains of typically developing children and those with ADHD or ASD. Eligibility: - Children between 4 and 8 years of age with ASD, ADHD, or children with no psychiatric diagnoses. Design: - Participants will be screened for eligibility. Those who are taking stimulant medication for ADHD or ASD will need to stop taking it for 3 days before the study visit. - After participating in a screening assessment, all participants will have one study visit. At this visit, they will have be asked to complete two tasks during a NIRS scan. For both tasks, they will react to images on a computer screen. This visit will last about 2 hours. - This is a testing study only. No blood or other samples will be needed for this study.

NCT ID: NCT01602016 Terminated - Clinical trials for Autism Spectrum Disorder

A Folinic Acid Intervention for Autism Spectrum Disorders

Start date: May 2012
Phase: Phase 2
Study type: Interventional

Researchers at Arkansas Children's Hospital Research Institute are conducting a study looking at the effects of Folinic Acid on language in Autism Spectrum Disorder and language impairment. The study has 3 phases. Phase 1 confirms that your child has language impairment (there is no compensation for this visit). If language impairment is verified in the phase 1 screening, then your child will be eligible for phase 2. Phase 2 consists of receiving 12 weeks of folinic acid or an inactive placebo, in addition to several evaluations of your child's abilities and a single blood test. Children that complete phase 2 will be eligible for a 12 week open-label trial of folinic acid which is phase 3.

NCT ID: NCT01592773 Terminated - Autism Clinical Trials

Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the long-term safety and tolerability of memantine in the treatment of pediatric patients with autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

NCT ID: NCT01388179 Terminated - Autism Clinical Trials

Deep rTMS (Repetitive Transcranial Magnetic Stimulation)for Treatment of Autism Symptoms in Children.

Start date: January 23, 2013
Phase: Phase 2
Study type: Interventional

Autism is a developmental disorder characterized by abnormalities in speech and communication, impaired social functioning, and repetitive behaviors and interests. The term "Autism spectrum disorders" or ASD is often used to include autistic disorder, Asperger syndrome and pervasive developmental disorder-not otherwise specified (PDD-NOS). Epidemiological research suggests that ASDs affect at least 60 per 10,000 youth, with estimates as high as 120 per 10,000. Severity of autistic features is not easily defined and the use of different diagnostic tools compounds the ability to lay a clear cut definition. It is, though, generally accepted that children with autism and normal IQ (>70) are "high functioning" regardless of the severity of their autistic features. The investigators will use the terms "autism" and "ASD" interchangeably, and the term "low functioning autism" will be used to describe those children with autism who have, or are presumed to have, IQ<70. The pathophysiology of autism has been studied extensively in the last decade. Abnormal neuronal connectivity has been implicated in a growing body of research. In addition, areas of over and/or under neuronal activation have been detected on functional MRI(Magnetic Resonance Imaging). Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive technique that allows to affect brain activity. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold, and is directed in an appropriate orientation relative to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating the neurons in the relevant brain structure. rTMS has been studied in individuals with high functioning autism. rTMS treatment was found to have an electrophysiological effect and to reduce repetitive behaviors and improved social functioning. In the context of existing pilot data suggesting effect of rTMS treatment in individuals with high functioning autism, the investigators propose a pilot study to assess the efficacy of rTMS in children and adolescents with low functioning autism.

NCT ID: NCT01322555 Terminated - Healthy Volunteers Clinical Trials

A Study of the Association Between Autism and Immune Changes in the Brain

Start date: March 4, 2011
Phase:
Study type: Observational

Background: - People with autism and autism spectrum disorders have problems with communication, behavior, and socializing, and many also have intellectual and developmental disabilities. The cause of autism is not known, but previous research has suggested an association between autism and immune changes in the brain. Researchers are interested in using the experimental radioactive drug (11C)PBR28, which attaches to a protein in the brain that is involved in immune changes, in positron emission tomography (PET) scanning of people with and without autism to see if there are greater immune changes in those with autism. Objectives: - To determine if positron emission tomography scanning can be used to evaluate changes in an immune system protein in the brains of people with autism. Eligibility: - Individuals between 18 and 45 years of age who have been diagnosed with either autism or autism spectrum disorders, or are healthy volunteers. Design: - Participants will be screened with a physical examination and psychological examination, medical history, questionnaires about behavior and mood, and blood and urine tests. - Participants will have two imaging studies of the brain at separate study visits. The first study visit will involve a magnetic resonance imaging (MRI) scan to provide a baseline image of the brain. The second study visit will involve PET scan with the radioactive chemical (11C)PBR28 to study immune system proteins in the brain. The MRI scan will take about 40 minutes, and the PET scan will take about 2 hours. - Participants will have a final study visit 24 hours after the PET scan to provide a final blood sample for testing.

NCT ID: NCT01172509 Terminated - Autism Clinical Trials

TMS Measures of Plasticity and Excitatory/Inhibitory Ratio as Biomarkers: R-baclofen Effects in Normal Volunteers

Start date: October 2010
Phase: Phase 1
Study type: Interventional

Our overall objective is to apply Transcranial Magnetic Stimulation (TMS) to develop measures of human synaptic plasticity and of brain excitatory:inhibitory ratio (E:I ratio), which we propose as novel biomarkers and outcome measures that will expedite clinical trials of treatments for Autism Spectrum Disorder (ASD). One potential therapeutic agent, R-baclofen will be investigated under this protocol. TMS is a safe, inexpensive and noninvasive means to focally stimulate the human brain. Presently, TMS is in extensive use as a means to measure regional brain excitability, which is dependent on local synaptic strength. TMS can be used to temporarily alter synaptic strength as well as to acutely measure levels of cortical excitability and short and long interval inhibition. Since altered synaptic plasticity and an imbalanced inhibitory:excitatory ratio are cited as fundamental abnormalities in ASD, we hypothesize that both severity of ASD-related learning deficits and their improvement after therapy will correlate with TMS measures of synaptic plasticity and E:I ratio. We propose to embed TMS measures of synaptic plasticity and E:I ratio in a 'Proof of Principal' trial of R-baclofen and to examine: Aim 1: Whether R-baclofen (a potential therapeutic agent for ASD) predictably alters TMS measures of synaptic plasticity and E:I ratio as a function of plasma concentration in adult volunteers. We will test the following hypotheses: 1. R-baclofen produces a significant change in TMS measures of LTD and E:I ratio; and 2. R-baclofen plasma levels and TMS measures of LTD and E:I ratio show a predictable exposure-response relationship. Exploratory Aim 1: Whether the presence of genetic polymorphisms of the BDNF and GABA-B receptor genes has a moderating effect on TMS measures and on R-baclofen effects. We will test the following hypotheses: 1. Presence of the BDNF val66met allele will be associated with decreased long-term depression (LTD) of cortical excitability 2. Polymorphisms of GABA-B receptor genes will be associated with altered magnitude of response to R-baclofen as measured by TMS

NCT ID: NCT01092208 Terminated - Autism Clinical Trials

Studies of Autistic Patients: Gene Networks and Clinical Subtypes

Start date: March 17, 2010
Phase:
Study type: Observational

Background: - Researchers who are studying autism spectrum disorders are interested in developing a collection of research samples from both children with autism and healthy individuals, some of whom may be related to the children with autism. - The genetic condition tuberous sclerosis, which can cause the growth of benign tumors in the brain and other parts of the body, is also linked with autism. Researchers have been able to determine the specific genetic mutations involved in tuberous sclerosis, and as a result are interested in studying the genetic information of children who have both tuberous sclerosis and autism, as well as tuberous sclerosis without autism. Objectives: - To develop a collection of DNA samples from blood and skin samples taken from children with autism and/or tuberous sclerosis, as well as healthy volunteers. Eligibility: - Children between 4 to 18 years of age who have autism and/or tuberous sclerosis, or are healthy volunteers. - Some of the healthy volunteers will be siblings of children with autism. Design: - Participants will be screened with a medical history and a physical examination, and may also have a genetic evaluation. - Participants will provide a blood sample and a skin biopsy for further study. - No treatment will be provided as part of this protocol.

NCT ID: NCT00917683 Terminated - Autism Clinical Trials

Investigation of Neuroserpin as an Autism Candidate Gene

Start date: June 2009
Phase: N/A
Study type: Observational

Previously it has been shown that Familial Encephalopathy with neuroserpin inclusion bodies (FENIB) patients develop abnormalities that partially overlap with Autism Spectrum disorders (ASD), confounded with additional features that could be explained by inclusion body formation not expected in subjects with inclusion body forming SERPINI1 mutations. There is no described human neuroserpin deficiency phenotype. The neuroserpin knockout mouse phenotype also suggests a possible overlap with autism. Neuroserpin could contribute directly at the synapse or through altered neuron migration during early development leading to the "underconnectivity" that underlies autism by potentially contributing to the excess of short connections and not enough long ones seen in autistic brains, possibly due to an imbalance in pruning of neurons and synapses early in life. It is thus proposed to sequence the neuroserpin gene in initially 20, and subsequently up to 100 idiopathic autistic patients selected as having the language impairment and perseveration endophenotypes.

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.