Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorSouthwest Autism Research & Resource Center

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

0 years through 17 years 11 months of age

Disqualifiers

History of a significant adverse reaction to a prior blood draw

In females of reproductive age, pregnancy or plans to become pregnant

Any other historical event/information that may, in the opinion of the PI, be a reason to exclude the child from participation.

Trial population

400 children aged 0 years to 17 years 11 months with a neurological, psychiatric or neurodevelopmental disorder. 250 children in this sample will have a known diagnosis of ASD: 50 children with a diagnosed MD (ASD/MD), 50 children with ruled out MD (ASD/NoMD), 150 children with ASD and unknown MD status. Comparison groups: 50 children with epilepsy (without ASD), 50 with psychiatric disorders, 50 with brain tumors (without ASD) 50 with a diagnosed MD (without ASD) Control group: 100 TD children (50 siblings of children with ASD and 50 without any siblings with ASD or developmental delay).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 9 trial groups

9

Trial groups

See each trial group below.

Group A: ASD (General)
Group B: ASD (With MD)
Group C: ASD (No MD)
Group D: Epilepsy
Group E: Brain Tumor
Group F: Psychiatric Disorder
Group G: MD (No ASD)
Group H: TD (With ASD Sibling)
Group I: TD (No ASD Sibling)

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to one year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southwest Autism Research & Resource Center

Lead sponsor

State University of New York - Downstate Medical Center

Collaborator