Recruiting

Observational Study

Sponsor:

Blinklab Limited

Code:

NCT07590973

Conditions

Autism

Autism Spectrum Disorder

Autism Spectrum Disorder (ASD)

Neurodevelopmental Conditions

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Accepted

Interventions

BlinkLab Dx1

Retrospective Neurodevelopmental Diagnostic Assessment

Study Details

Brief summary:

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.

Conditions

Autism

Autism Spectrum Disorder

Autism Spectrum Disorder (ASD)

Neurodevelopmental Conditions

Study ID

NCT07590973

Start date

Feb 15, 2025

Status verified date

May, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 11

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age: Children between 2 to 11 years old
2. Parent/Caregiver/Healthcare Provider Concern: The child has received a diagnostic outcome of a neurodevelopmental assessment based on DSM-5 criteria within the past 12 months.
3. Language Proficiency: Parents and subjects must have functional English capability in the home environment.
4. Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF).
5. Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App.

Exclusion Criteria:

1. Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.
2. Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.
3. Location of at home testing: Not being able to complete all remote at-home study sessions within the US.
4. History of audiogenic seizures: Participants with a known history of seizures that are triggered by auditory stimuli, including reflex or startle epilepsy provoked by sounds (audiogenic seizures), or any other form of sound-induced epilepsy.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

BlinkLab Dx1

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

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.

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) ]
  • Specificity 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 and Locations

Central contacts

Myrthe J. Ottenhoff, MD, PhD

908-824-3471study@blinklab.org

Locations

Remote study conducted nationwide; all participation occurs via smartphone app at home.

Recruiting

Princeton, New Jersey, United States, 08540

Contacts

Myrthe J. Ottenhoff, MD, PhD

908-824-3471study@blinklab.org

More Information

Sponsor

Blinklab Limited

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • Autism Spectrum Disorder
  • Autism
  • Autism Diagnosis
  • Neurodevelopmental Conditions
  • Pediatric Assessment
  • Digital Assessment
  • Mobile Application
  • Smartphone-based Assessment
  • Digital Health
  • Remote Study
  • Observational Study
  • Eye Movements
  • Repetitive Behavior
  • Reflexive Sensorimotor Behavior
  • Machine Learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Blinklab Limited on 2026-05-15.