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Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders

RECRUITINGSponsored by Southwest Autism Research & Resource Center
Actively Recruiting
SponsorSouthwest Autism Research & Resource Center
Started2023-12-13
Est. completion2028-12-31
Eligibility
Healthy vol.Accepted
Locations2 sites

Summary

The study involves up to 5 visits for a fasting blood draw, 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.

Eligibility

Healthy volunteers accepted
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.

Conditions7

Autism Spectrum DisorderBrain TumorCancerEpilepsyMitochondrial DiseasesMitochondrial PathologyPsychiatric Disorder

Locations2 sites

Arizona

1 site
Southwestern Research and Resource Center
Phoenix, Arizona, 85016
Christopher J Smith, PhD602-218-8192

New York

1 site
State University of New York, Downstate
Brooklyn, New York, 11203
Harris Huberman, MD718-270-2272harris.huberman@downstate.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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