NCT06213090

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Feb 2024Dec 2030

First Submitted

Initial submission to the registry

January 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

6.9 years

First QC Date

January 4, 2024

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

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.

    up to 7 years

Secondary Outcomes (2)

  • 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 Arms (10)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children who present to Rossignol Medical Center for standard care related to neurodevelopmental disorders.

You may qualify if:

  • Neurodevelopmental delays Clinical visit at an Rossignol Medical Center

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rossignol Medical Center

Phoenix, Arizona, 85050, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, cerebrospinal fluid, muscle, and skin samples may be retained.

MeSH Terms

Conditions

Neurodevelopmental DisordersAutism Spectrum DisorderPediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infectionsPediatric acute-onset neuropsychiatric syndromeDown SyndromeEpilepsyMitochondrial EncephalomyopathiesNeurodegeneration Due To Cerebral Folate Transport Deficiency

Condition Hierarchy (Ancestors)

Mental DisordersChild Development Disorders, PervasiveIntellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, InbornBrain DiseasesCentral Nervous System DiseasesMitochondrial MyopathiesMuscular DiseasesMusculoskeletal DiseasesBrain Diseases, MetabolicNeuromuscular DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesMitochondrial Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 19, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations