NCT07590973 Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
| NCT ID | NCT07590973 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Blinklab Limited |
| Condition | Autism |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-02-15 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-02-15 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07590973 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 11 Years, studying Autism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07590973 currently recruiting?
Yes, NCT07590973 is actively recruiting participants. Contact the research team at study@blinklab.org for enrollment information.
Where is the NCT07590973 trial being conducted?
This trial is being conducted at Princeton, United States.
Who is sponsoring the NCT07590973 clinical trial?
NCT07590973 is sponsored by Blinklab Limited. The trial plans to enroll 1,000 participants.