View clinical trials related to Autism.
Filter by:The proposed study attempts to deepen our understanding of repetitive behaviors in autism spectrum disorders (ASD) and its treatment by examining the changes in key neural circuits associated with risperidone treatment using functional MRI. This study is a substudy of a larger center grant (IRB#07-03-066). Other studies also under this center grant, include: IRB#03-02-085, IRB#95-01-028. All participants will have the option to enter another sub-study, should they meet criteria. The proposed study will address this aim by mounting a controlled trial of 52 children with Autism Spectrum Disorder. After screening assessment, children will enter a three-part study. Phase 1 will be an 8-week, double-blind, placebo-controlled flexible dose trial of risperidone. The extension phase is a 16-week open-label maintenance phase for responders to risperidone or placebo. Non-responders to placebo will be invited to enroll in the eight-week open-label study. 48 of the participants will also undergo fMRI at Week 8 while on blinded treatment, as an optional sub-study. The medication will be dispensed in a liquid suspension and the dose will range from 0.5 mg to 4.0mg.
Background: - Electroencephalography (EEG) records electric patterns produced by the brain, and can detect conditions such as epilepsy or other l abnormalities that may affect brain function. In EEG studies, electric patterns that resemble epileptic seizures are known as epileptiform pattern. These patterns are associated with an increased risk of seizures, even in people who have not been diagnosed with epilepsy. Epileptiform patterns also appear on the EEGs of some children who have autism spectrum disorders but do not have epilepsy. It is unclear if these discharges are related in any way to the symptoms of autism (behavior, language or intellectual abilities). - Divalproex sodium (Depakote) is a drug that has been used for many years to treat epilepsy and other brain disorders in children and adults. Researchers are interested determining whether treatment with divalproex sodium can reduce epileptiform patterns in children with autism spectrum disorders, and in doing so study whether this treatment can improve behavior, language or cognition in children with autism spectrum disorders. Objectives: - To study the effectiveness of using divalproex sodium to reduce epileptiform EEG discharges in children with autism spectrum disorders. Eligibility: - Children between 3 and 10 years of age who have an autism spectrum disorder and show frequent epileptiform discharges on an overnight EEG. Design: - This study will last for a total of 9 months, with 6 months of treatment with either divalproex sodium or a placebo followed by 3 months of treatment with divalproex sodium only. - Potential participants will be screened with a physical examination and medical history, blood samples, and psychological tests, and will spend the night in the NIH Clinical Center to have an overnight EEG. Children with frequent epileptiform abnormalities on the EEG will continue with the study; all others will be considered ineligible. - Eligible participants will receive either divalproex sodium or a placebo to be taken twice daily for 24 weeks. Neither the investigators nor the participants will know which they are taking. - Participants will have regular visits (every 2-4 weeks) to monitor for adverse effects and to test for possible behavioral improvement, and will also have overnight EEG testing at 12 and 24 weeks. - At the end of the 24-week study period, participants will have the option to have an additional 12 weeks of treatment with divalproex sodium. - A final evaluation (including EEG) will be conducted at the end of the final treatment period.
This study is working towards gaining a better understanding of the genetic and environmental factors involved in autism spectrum disorders (ASD), which includes autism, pervasive developmental disorder (PDD), and Asperger's syndrome. The investigators hope that information gained from this study will lead to new ways of diagnosing and treating ASDs.
Neurofeedback, a neuro-cognitive training method based on operant conditioning, will be employed with 90 children with the Autistic Spectrum Disorders (ASD) over a 60 session training period to improve the limiting behavioral and sensory symptoms Autism presents (with each collaborative site working with 45 of the 90 participants). This study seeks to demonstrate that Neurofeedback training, a non-invasive approach based on Learning Theory, will mitigate presenting symptoms of Autism, and ultimately render the person with Autism significantly more able to interact with his/her environment successfully, independently function on a day-to-day basis, and improve overall mental health.
Doctors at MassGeneral Hospital for Children (MGHfC) are doing a research study to learn if a gluten free-dairy free (GFCF) diet is helpful in improving gastrointestinal symptoms associated with autism. Hypothesis: The gluten free/casein free diet (GFCF) will result in a higher proportion of subjects having reduction in gastrointestinal (GI) symptoms associated with autism spectrum disorders (ASD). Primary Study Objective: - To assess the effect of a GFCF diet on GI symptoms associated with ASD. Secondary Objectives: - To assess if improvements in GI symptoms result in improvements in autistic behavior when using a GFCF diet in the dietary management of GI symptoms associated with ASD - To determine the nutritional impact of a GFCF restrictive diet - To assess the role of food allergies in the manifestation of GI symptoms This is a 14-week study that requires between 5 & 9 office visits. All study related activities -including physical exams, blood samples and allergy testing - and an amino acid based supplement drink, are at no cost. Research study visits will take place at MGHfC in Boston, or at Newton Wellesley Hospital in Newton, or at Lurie Center/LADDERS in Lexington.
We propose a study which will combine multiple modalities in evaluating the treatment response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE) inhibitors and choline supplements. The primary objective of the study is to examine the efficacy of this treatment in improving core autistic symptoms. The Secondary objective of the study is to evaluate the safety and tolerability of the treatment protocol in ASD children. Exploratory objectives include evaluation of the influence of the treatment on linguistic performance, comorbid behaviors, adaptive functioning and executive functions.
This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include: 1. Exposure during pregnancy to CBZ, LTG, and VPA, each as monotherapy, is associated with developmental delay with or without signs of autism. 2. Exposure to each drug (CBZ, LTG, and VPA) as monotherapy is associated with an increased rate of occurrence of major malformations. 3. The child with major malformations is more likely to have developmental delay with or without signs of autism than the child who does not have major malformations. 4. The occurrence of adaptive behavior outcomes will show a dose-response relationship with the dose of medication taken by the mother in the first trimester. The study population includes children 36-83 months of age who were exposed throughout gestation to one of the three drugs of interest, as treatment for maternal seizure disorder.
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.
The purpose of this study is to see if memantine is helpful in managing problematic symptoms in adults with autism, Asperger's disorder, or Pervasive Developmental Disorder NOS.
Background: - Research into the genetic causes of autism spectrum disorder (ASD) involves studies of the DNA of children with autism. New DNA sequencing technology allows researchers to study specific genes in search of genetic changes that may cause or contribute to ASD. Individuals who donated DNA to the Autism Genetic Resource Exchange may benefit from further study of their DNA samples with more advanced DNA sequencing technology. - The role of cholesterol in individuals with ASD is currently under investigation. Research has suggested that abnormal cholesterol levels in children with autism may be related to genetic mutations or changes in how cholesterol is regulated in the body. Objectives: - To study existing blood samples of children with autism spectrum disorders to evaluate the relationship between genetic traits and cholesterol function. Eligibility: - Children with ASD who donated blood samples to the Autism Genetic Resource Exchange. Design: - Parents/guardians of minor children with ASD will provide consent for further research to be performed on existing DNA samples in the Autism Genetic Research Exchange databank. Information from this research may be provided to the consenting parents/guardians on a case by case basis, as directed by the researchers.