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โ† Trials
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Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism

Recruitingn/aAges 2 Years - 11 YearsAllBlinklab Limited
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In plain words

What the trial is, and whether it could suit you

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 co

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • BlinkLab Dx1
  • Retrospective Neurodevelopmental Diagnostic Assessment
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Where

1 site
Remote study conducted nationwide; all participation occurs via smartphone app at home.
Princeton, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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