NCT07590973Recruiting
Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 11 May 2026
- Start date
- 15 Feb 2025
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Blinklab Limited
- Diseases
- Autism
- NCT number
- NCT07590973
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 15 Feb 2025 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.
Other illness
- 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.
Other
- Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.
- Location of at home testing: Not being able to complete all remote at-home study sessions within the US.
Who the study is looking for
- Age: Children between 2 to 11 years old
- 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.
- Language Proficiency: Parents and subjects must have functional English capability in the home environment.
- Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF).
- Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App.
Age in the registry: 2 years to 11 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Remote study conducted nationwide; all participation occurs via smartphone app at home. Coordinator of this site? Confirm its status | Princeton | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.