Patterns of Neurodevelopmental Disorders

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213090
• Other study ID #: NeuroClinical
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2024
• Source: Rossignol Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Neurodevelopmental delays Clinical visit at an Rossignol Medical Center

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Down Syndrome
• Epilepsy
• Folic Acid Deficiency
• Mitochondrial Encephalomyopathies
• Neurodevelopmental Disorders
• Pediatric Acute-Onset Neuropsychiatric Syndrome
• Streptococcal Infections
• Syndrome

Locations

Country	Name	City	State
United States	Rossignol Medical Center	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Richard Frye	Autism Discovery and Treatment Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 7 years
Secondary	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.	up to 7 years
Secondary	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.	up to 7 years

External Links

•   Autism Discovery and Treatment Foundation
•   Rossignol Medical Center