Patterns of Neurodevelopmental Disorders

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Recruiting
      • Rossignol Medical Center
      • Contact: Richard E Frye, MD, PhD; Phone Number: 281-546-8377; Email: drfrye@rossignolmedicalcenter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

Inclusion Criteria:

Neurodevelopmental delays Clinical visit at an Rossignol Medical Center

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Richard Frye
• Collaborators: Autism Discovery and Treatment Foundation

Publications and helpful links

Helpful Links

• Rossignol Medical Center
• Autism Discovery and Treatment Foundation

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Nutrition Disorders; Genetic Diseases, Inborn; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Avitaminosis; Deficiency Diseases; Malnutrition; Intellectual Disability; Brain Diseases, Metabolic; Child Development Disorders, Pervasive; Mitochondrial Diseases; Abnormalities, Multiple; Chromosome Disorders; Vitamin B Deficiency; Mitochondrial Myopathies; Syndrome; Autism Spectrum Disorder; Down Syndrome; Folic Acid Deficiency; Neurodevelopmental Disorders; Mitochondrial Encephalomyopathies; Streptococcal Infections
• Other Study ID Numbers: NeuroClinical

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified IPD may be shared on a case by case basis

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No