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RecruitingNCT06213090Updated Apr 16, 2026

Patterns of Neurodevelopmental Disorders

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

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 9 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,000
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

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

Neurodevelopmental Disorders

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 →

Lead sponsor

Richard Frye is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

Neurodevelopmental delays Clinical visit at an Rossignol Medical Center

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Autism

    Children with autism will be followed in regards to their clinical management.

  • Mitochondrial Encephalopathy

    Children with Mitochondrial Encephalopathy will be followed in regards to their clinical management.

  • Down Syndrome

    Children with Down Syndrome will be followed in regards to their clinical management.

  • Cerebral Folate Deficiency

    Children with Cerebral Folate Deficiency will be followed in regards to their clinical management.

  • PANS

    Children with PANS will be followed in regards to their clinical management.

  • PANDAS

    Children with PANDAS will be followed in regards to their clinical management.

  • Epilepsy

    Children with Epilepsy will be followed in regards to their clinical management.

  • ADHD

    Children with ADHD will be followed in regards to their clinical management.

  • Dyslexia and other learning disabilities

    Children with Dyslexia and other learning disabilities will be followed in regards to their clinical management.

  • Other Neurodevelopmental Disorders

    Children with Other Neurodevelopmental Disorders will be followed in regards to their clinical management.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Deidentified IPD may be shared on a case by case basis

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06213090
Lead sponsor
Richard Frye
Collaborators
Autism Discovery and Treatment Foundation
Responsible party
Richard Frye (Principal Investigator, Rossignol Medical Center) — Sponsor-investigator
First posted
Jan 19, 2024
Start date
Feb 1, 2024
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Apr 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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