Feasibility of EEG and ET measures in young children with Autism Spectrum Disorder

Autism Biomarkers Consortium for Clinical Trials (ABC-CT) Pre-School Feasibility Study

This study is testing if brain activity and eye movement tracking can help us understand Autism Spectrum Disorder in young children aged 3-5.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 3 Years to 5 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 5 sites (Los Angeles, California and 4 other locations)
• Trial ID: NCT06413316 on ClinicalTrials.gov

What this trial studies

This multicenter study aims to assess the feasibility of using EEG and eye-tracking (ET) measures in children aged 3-5 years with Autism Spectrum Disorder (ASD) and typically developing (TD) peers. The study will collect data to evaluate the reliability and validity of these measures as potential biomarkers for ASD. Additionally, blood samples will be obtained from participants and their biological parents for future genomic analyses. The findings will contribute to the development of promising biomarkers through the FDA Biomarker Qualification Program.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 3-5 years who have a diagnosis of Autism Spectrum Disorder or are typically developing.

Not a fit: Patients who are outside the age range of 3-5 years or do not meet the diagnostic criteria for ASD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to the identification of reliable biomarkers for early diagnosis and intervention in children with Autism Spectrum Disorder.

How similar studies have performed: Previous studies have explored EEG and ET measures in older populations, but this specific approach in preschool-aged children with ASD is novel and untested.

Eligibility criteria

Inclusion Criteria:

For All Subjects:

1. Children (regardless of biological sex) Age 3 - 5. Participants must be able to complete the study before turning 6.
2. Written parental permission will be obtained prior to any study procedures. Child verbal assent will be obtained.
3. IQ 60-150 (ASD) and 80-150 (TD) as assessed by the Differential Ability Scales - 2nd Edition or developmental level via Mullen Scales of Early Learning Composite (ELC).
4. Participant and parent/guardian must be English speaking.

For ASD Participants (only):

1. Diagnosis of ASD based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the BOSA or Autism Diagnostic Observation Schedule (ADOS-2) and short form (ADI-R) scored age appropriately. Diagnostic evaluations will be completed by research staff and supervised by a licensed psychologist.
2. If parents are biological, a minimum of the child and one parent will be required to consent to the blood draw procedure. It is preferred that the child and both biological parents participate in the blood draw procedure. The inability to obtain blood samples will not be exclusionary.

Exclusion Criteria:

For All Subjects:

1. Known genetic or neurological syndrome with an established link to autism (in addition to ASD for ASD participants)

   1. This does not include events in which the link to ASD is less well known/established (e.g., 16p11.2 CNVs, CHD8 mutations, Trisomy 21, 22q deletion syndrome, Dup 15q Syndrome).
   2. Specific cases will be discussed with the clinical team who will make a final determination, as needed.
2. History of epilepsy or seizure disorder

   a. This does not include history of simple febrile seizures or if the child is seizure free (regardless of the seizure type) for the past year.
3. Motor or sensory impairment that would interfere with the valid completion of study measures including significant hearing or vision impairment not correctable by a hearing aid or glasses/contact lenses. Children who wear bifocal or progressive lenses are not eligible.
4. Children who are taking neurological or psychiatric medications that are not stable on prescription or dose for 8 weeks prior to D1.

   a. Medication is not exclusionary. Children taking neurological or psychiatric medications, including anti epileptics and psychopharmacological agents, must be stable on the medication and dose for 8 weeks prior to D1.
5. History of significant prenatal/perinatal/birth injury as defined by birth \<36 weeks AND weight \<2000 grams (approximately 4.5.lbs).
6. History of neonatal brain damage. (e.g., with diagnosed hypoxic or ischemic event).
7. Any other factor that the investigator feels would make assessment or measurement performance invalid.

For ASD Participants (only):

1. Any known environmental circumstances that is likely to account for the picture of autism in the proband (severe nutritional or psychological deprivation etc.)

For TD Participants (only):

1. Known historical diagnosis of ASD or a sibling with ASD.
2. Criteria score in the ASD range on the BOSA/ADOS
3. Active psychiatric disorder (depression, anxiety, ADHD, etc.) and/or any current treatment (medication or other treatment) for a psychiatric condition.

   1. Participants will be screened using the (ECI-5 or CSI-4). Due to the instrument's high sensitivity and potential for false positives, any score in the clinical range will be reviewed by research staff for determination of eligibility.

Where this trial is running

Los Angeles, California and 4 other locations

• Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
• Yale Child Study Center — New Haven, Connecticut, United States (Recruiting)
• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: James McPartland, PhD — Yale University
• Study coordinator: James McPartland, PhD

Conditions Autism Spectrum Disorder; Biomarker