Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism

Part of paid clinical trials in Princeton, New Jersey.

Sponsor
Blinklab Limited
Study ID
NCT07590973
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 11 Years
Healthy Volunteers
Accepted

Interventions

  • BlinkLab Dx1 — DIAGNOSTIC_TEST
    BlinkLab Dx1 is a machine learning-based algorithm that generates a continuous score reflecting likelihood of autism from neurobehavioral responses (including measures such as pre-pulse inhibition and habituation, motor activity, and vocalizations) recorded during standardized video-watching sessions in a mobile application. Pre-specified thresholds, determined during model development and fixed prior to evaluation in the independent test dataset, are applied to categorize results as " Positive for autism", "Intermediate" or "Nagative for autism". Results in the intermediate category are considered indeterminate and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.
  • Retrospective Neurodevelopmental Diagnostic Assessment — BEHAVIORAL
    The clinical reference standard is a retrospective neurodevelopmental diagnostic assessment conducted within 12 months prior to enrollment, based on DSM-5 criteria. Participants are classified as having or not having an autism diagnosis based on the documented diagnostic conclusions of these assessments.

Study Details

This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11. BlinkLab Dx1 is a non-invasive, smartphone-based application under development as a diagnostic aid for healthcare providers assessing autism. In this study, children who have undergone a neurodevelopmental assessment within the past 12 months will complete two short, video-based sessions using the BlinkLab Dx1 app. The app presents visual and auditory stimuli and records reflexive sensorimotor responses and patterns of repetitive behavior. Additionally, primary caregivers will answer a short questionnaire in the app about symptoms and development. Information about prior neurodevelopmental assessments, including documented DSM-5-based diagnoses from routine clinical practice, will be collected retrospectively. The study will examine how the app's neurobehavioral measurements relate to previously assigned clinical diagnoses. These paired data will be used to develop and evaluate a machine learning-based algorithm using separate training and testing datasets to assess whether patterns measured by BlinkLab Dx1 can help distinguish children with autism from children without an autism diagnosis. This study does not involve any treatment or medical intervention.

Key Dates

Start date
Feb 15, 2025
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Model Development Group - Children evaluated for neurodevelopmental conditions.
    Children aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition.
  • Arm: Model Testing Group - Children evaluated for neurodevelopmental conditions.
    Children aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition. Data collection for this group is blinded.

Primary Outcome Measure

Sensitivity of BlinkLab Dx1 [ Time Frame: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Remote study conducted nationwide; all participation occurs via smartphone app at home.PrincetonNew Jersey08540
Myrthe J. Ottenhoff, MD, PhD
[email protected]
908-824-3471

Find similar trials in Princeton, NJ

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Remote study conducted nationwide; all participation occurs via smartphone app at home.· Princeton, NJ

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