Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism (NCT07590973) | Clinical Trial Compass
RecruitingNot Applicable
Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
United States1,000 participantsStarted 2025-02-15
Plain-language 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.
Who can participate
Age range
2 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of BlinkLab Dx1
Timeframe: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
2
Specificity of BlinkLab Dx1
Timeframe: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
. Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.
. Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.
. Location of at home testing: Not being able to complete all remote at-home study sessions within the US.
. 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.