Epilepsy Clinical Trial
Official title:
Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
Researchers in the Neurodevelopmental Division at Phoenix Children's Hospital are conducting a study about mitochondrial function in children with autism spectrum disorder (ASD). The study involves up to 5 visits to Phoenix Children's Hospital with fasting blood draws, behavioral assessments, and/or questionnaires. Other samples may be collected when appropriate. This study is currently recruiting. There is no cost for visits or study-related exams.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | January 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria (ASD): 1. ASD, as defined by either a gold standard measure for ASD diagnosis, the Autism Diagnostic Observation Schedule (ADOS); the Autism Diagnostic Interview-Revised (ADI-R); and/or a comprehensive assessment that is consistent with ASD, in the opinion of the principal investigator. For those the PI believes a prospective diagnosis of ASD is warranted, a formal diagnostic assessment will be scheduled at screening. 2. 0 years through 17 years 11 months of age Inclusion Criteria (TD, MD, Epilepsy, Brain Tumor, Psychiatric) 1. 0 years to 17 years 11 months of age Exclusion Criteria (All): 1. History of a significant adverse reaction to a prior blood draw 2. In females of reproductive age, pregnancy or plans to become pregnant 3. Any other historical event/information that may, in the opinion of the PI, be a reason to exclude the child from participation. |
Country | Name | City | State |
---|---|---|---|
United States | State University of New York, Downstate | Brooklyn | New York |
United States | Southwestern Research and Resource Center | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Southwest Autism Research & Resource Center | State University of New York - Downstate Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mitochondrial Reserve Capacity measured using the Seahorse XR Flux Analyzer | Children with ASD will be differentiated from all other cohorts and have a specific pattern of mitochondrial dysfunction that will be different from and comparable to other groups of children in the study (e.g. mitochondrial disease without autism, typically developing, autism with mitochondrial disease, and developmental delay). It is hypothesized that these children will have a more pronounced delay in their development and will have a higher probability for poor developmental and behavioral outcomes. This will be evaluated using a Seahorse XR flux analyzer to generate a maximal reserve capacity value. | Up to one year |
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