Patterns of Neurodevelopmental Disorders

Recruiting

• Conditions: Down Syndrome; Cerebral Folate Deficiency; Mitochondrial Encephalomyopathies; Epilepsy; Pediatric Acute-Onset Neuropsychiatric Syndrome; Neurodevelopmental Disorders; Autism Spectrum Disorder; Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection

• Registration Number: NCT06213090
• Lead Sponsor: Richard Frye

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-19
• Study Start: 2024-02-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Neurodevelopmental delays Clinical visit at an Rossignol Medical Center

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients with Specific Medical abnormalities	up to 7 years	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.

Secondary Outcome Measures

Name	Time	Method
The number of children with abnormal clinical lab	up to 7 years	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.
The number of children who respond to specific treatments	up to 7 years	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.

Trial Locations

Locations (1)

Rossignol Medical Center; 🇺🇸 Phoenix, Arizona, United States