An observational study in Neurodevelopmental Disorders, Autism Spectrum Disorder and Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection, sponsored by Richard Frye. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Richard Frye · Observational
The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.
Although neurodevelopmental disorders are very prevalent (for example Autism affects 1 out of every 36 children and dyslexia affects up to 15% of the population), the etiology of such disorders is not known. The purpose of this investigation is to identify common etiologies of neurodevelopmental disorders (i.e., speech delay, global developmental delay, autism) and determine if it is possible to find early indicators of the diagnosis and foster the potential for a better prognosis of these disorders. At this time the investigators examine patients with neurodevelopment disorders with various medical investigations, but the results of these investigations are not systematically evaluated. One of the goals of this research is to systematically examine this information in order to identify patterns of test abnormalities that have not been previously described. Another goal of this research is to identify the common etiologies typically identified by the medical evaluation, so we can further refine our approach. In addition, the investigators now have the ability to evaluate biological samples for biomarkers that have potential to be diagnostically useful.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 133 observational studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →Richard Frye is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Children who present to Rossignol Medical Center for standard care related to neurodevelopmental disorders.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Neurodevelopmental delays Clinical visit at an Rossignol Medical Center
Exclusion Criteria:
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Children with autism will be followed in regards to their clinical management.
Children with Mitochondrial Encephalopathy will be followed in regards to their clinical management.
Children with Down Syndrome will be followed in regards to their clinical management.
Children with Cerebral Folate Deficiency will be followed in regards to their clinical management.
Children with PANS will be followed in regards to their clinical management.
Children with PANDAS will be followed in regards to their clinical management.
Children with Epilepsy will be followed in regards to their clinical management.
Children with ADHD will be followed in regards to their clinical management.
Children with Dyslexia and other learning disabilities will be followed in regards to their clinical management.
Children with Other Neurodevelopmental Disorders will be followed in regards to their clinical management.
Number of Patients with Specific Medical abnormalities
It is unknown if a specific set of biological abnormalities contribute to the formation of many types of neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders. The chart will be reviewed for medical diagnoses other than the primary neurodevelopmental disorders.
Time frame: up to 7 years
The number of children with abnormal clinical lab
It is unknown if a abnormalities in specific clinical laboratories are associated with specific neurodevelopmental disorders. The study is intended to identify the relationship between biological abnormalities and neurodevelopmental disorders. The medical chart will be reviewed to determine the number of children with a specific medical disorder who have abnormalities in specific clinical labs.
Time frame: up to 7 years
The number of children who respond to specific treatments
Various behavioral and medical treatments are used for many types of neurodevelopmental disorders but the effectiveness for many of these treatments is not known. The study is intended to identify the relationship between biological abnormalities (and their treatments) and neurodevelopmental disorders. The medical chart will be review to determine the treatments applied to each participant and the participants response.
Time frame: up to 7 years
Plan to share: Undecided — Deidentified IPD may be shared on a case by case basis
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Neurodevelopmental Disorders →
Richard Frye