Observational Study of Neurogenetic Disorders

This study is looking at individuals with neurodevelopmental disorders (problems with brain development that affect how a person functions), intellectual disability, developmental delay, autism, or seizures. Researchers want to understand patterns in people who have a confirmed genetic change (variant) in any gene, especially those in the hnRNP family of genes. They will look at medical information already collected, and also ask participants to complete questionnaires and assessments. The goal is to learn more about how these genetic changes affect health, learning, and behavior over five years.

Study design
This is an observational study, meaning there are no interventions or treatments being tested. Researchers plan to include about 1000 participants.
What's involved
You would provide existing medical data and may be asked to complete questionnaires, neuropsychological assessments (tests of brain function), motor assessments (tests of movement), and electroencephalography (EEG, a test that measures brain activity).
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for five years to assess medical abnormalities, education-based impairments, and repetitive behaviors.

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NCT03492060

Longitudinal Study of Neurogenetic Disorders

Recruiting
Not specifiedAll AgesObservational
Columbia University
~1,000 participants
Updated 2025-10-27 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Medical abnormalities associated with genetic variants
Measured over 5 years
+17 more outcomes measured
Neurodevelopmental Disorders
Intellectual Disability
Developmental Delay
Autism Spectrum Disorder
Seizures
Hypertonia, Muscle
Hypotonia
1 sites across 1 states
New York1
  • Jennifer M. Bain, MD, PhD · PRINCIPAL_INVESTIGATOR · Columbia University

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Eligibility criteria

Inclusion

Individuals must have had whole genome/exome sequencing and have a confirmed variant in any gene.

Exclusion

Subjects who cannot provide genetic confirmation of a predicted deleterious variant in any gene.
  • Medical abnormalities associated with genetic variants5 years

    Gene variants are known to result in a variety of clinical phenotypes. The study is intended to accrue data from medical records that document the range of neurological phenotypes and explore their incidence and frequency across genetic cohorts.

  • Education-based impairments associated with genetic variants5 years

    The study seeks to collect records from the schools attended by participants; including: Individualized Education Programs (IEPs) and school records. We intend to use these records, in tandem with medical records, to explore meaningful statistical and clinical relationships in the phenotypes expressed by the population of the study.

  • Repetitive Behavior5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and repetitive behavior (measured by the Repetitive Behavior Scale - Revised; RBS-R)

  • Sleep Habits5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and sleep habits (measured by The Children's Sleep Habits Questionnaire; CSHQ)

  • Sensory Issues5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and sensory issues (measured by The Short Sensory Profile; SSP)

  • Social Interaction and Communication SRS-II Score5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and social interaction and communication issues (measured by The Social Responsiveness Scale - Second Edition; SRS-II)

  • Anxiety5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and anxiety (measured by The Spence Children's Anxiety Scale - Preschool and Parent Reports; SCAS - Preschool and SCAS - P)

  • Receptive Language Skills5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and receptive language skills (measured by a 20-item music exposure questionnaire evaluating exposure on a 3-point scale: rarely, sometimes, often; and an EEG with music paradigm)

  • Executive Functioning5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and executive functioning (measured by The Behavior Rating Inventory of Executive Function - Parent Report; BRIEF-P)

  • Autism5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and autism (measured by The Childhood Autism Rating Scale; CARS)

  • Adaptive Behavior5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and adaptive behavior (measured by The Vineland Adaptive Behavior Scales, Third Edition; Vineland - 3)

  • Social Interaction and Communication SCQ Score5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and social interaction and communication issues (measured by The Social Communication Questionnaire; SCQ)

  • Emotional Regulation5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and emotional regulation (measured by The Behavioral Assessment System for Children - Third Edition; BASC - 3)

  • Motor Performance5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and motor performance (measured by The Movement Assessment Battery for Children - Second Edition; MASC-II)

  • Function in Daily Activities, Mobility, Social and Cognitive, and Responsibility5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and functional capability in daily activities and mobility (measured by The Pediatric Evaluation of Disability Inventory Computer Adaptive Test; PEDI-CAT)

  • Functional Balance5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and functional balance and gross motor function (measured by a 14-item Pediatric Balance Scale)

  • Functional Capability and Mobility5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and functional mobility (measured by an 11-point Movement Questionnaire)

  • Coordination and Gait5 years

    Correlations (r) between mutant allele (obtained from retrospective data) and gait (measured by a Kinematic Evaluation utilizing Solesound Pedishoe Sandals and GaitRite Walkway)