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Clinical Trials/NCT06213090
NCT06213090
Recruiting
Not Applicable

Patterns of Disease, Outcomes and Treatment Response in Children With Neurodevelopmental Disorders

Richard Frye1 site in 1 country1,000 target enrollmentFebruary 1, 2024

Overview

Phase
Not Applicable
Intervention
Cerebral Folate Deficiency
Conditions
Neurodevelopmental Disorders
Sponsor
Richard Frye
Enrollment
1000
Locations
1
Primary Endpoint
Number of Patients with Specific Medical abnormalities
Status
Recruiting
Last Updated
16 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
December 31, 2030
Last Updated
16 days ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Richard Frye
Responsible Party
Sponsor Investigator
Principal Investigator

Richard Frye

Principal Investigator

Rossignol Medical Center

Eligibility Criteria

Inclusion Criteria

  • Neurodevelopmental delays Clinical visit at an Rossignol Medical Center

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

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.

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.

Outcomes

Primary Outcomes

Number of Patients with Specific Medical abnormalities

Time Frame: 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 Outcomes

  • The number of children with abnormal clinical lab(up to 7 years)
  • The number of children who respond to specific treatments(up to 7 years)

Study Sites (1)

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