Identifying metabolic and immune biomarkers in neurological disorders
Official title: Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders
Run by Southwest Autism Research & Resource Center · NCT04322734 · Data updated 2026-11-12
This study is trying to see if measuring mitochondrial function can help identify children with neurological disorders like autism and epilepsy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Southwest Autism Research & Resource Center Academic / other |
| Locations | 2 sites (Phoenix, Arizona and 1 other locations) |
| Status | Recruiting |
| Started | December 13, 2023 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT04322734 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include children aged 0 to 17 years with Autism Spectrum Disorder, mitochondrial pathology, epilepsy, brain tumors, or psychiatric disorders.
✕Probably not a fit
Patients with a history of significant adverse reactions to blood draws or those who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the role of mitochondrial function in various neurological and neurodevelopmental disorders, including Autism Spectrum Disorder, epilepsy, and brain tumors. Participants will undergo up to five visits for fasting blood draws, behavioral assessments, and questionnaires to collect relevant data. The study seeks to develop a non-invasive method to measure mitochondrial function variations using the Seahorse Analyzer, which could help identify children with medical disorders linked to mitochondrial dysfunction. The research is designed to enhance understanding of how mitochondrial health impacts these conditions.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for children with neurological and neurodevelopmental disorders.
How similar studies have gone: While mitochondrial dysfunction has been studied in relation to various conditions, this specific approach using the Seahorse Analyzer for non-invasive assessment is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Southwestern Research and Resource Center
Phoenix, Arizona, United States Recruiting -
State University of New York, Downstate
Brooklyn, New York, United States Recruiting
Study contacts
- Study coordinator: Richard E Frye, MD, PhD
- Email: DrFrye@AutismDiscovery.org
- Phone: 844-ADTFRes
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.