Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
11 maj 2026 uppdaterad av: Blinklab Limited
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.
Studieöversikt
Status
Rekrytering
Intervention / Behandling
Detaljerad beskrivning
Specification of the Time Perspective section in the Study Design: this study has a hybrid time perspective, as BlinkLab Dx1 measures are collected prospectively during remote sessions, while the clinical reference standard (presence of in a DSM-5-based diagnostic report from a neurodevelopmental assessment within the prior 12 months) is collected retrospectively. The clinical reference standard is based on neurodevelopmental assessments conducted in routine clinical care and is collected without influence from study procedures.
The study will use paired BlinkLab Dx1 measurements and clinical reference standard diagnoses to develop and evaluate a machine learning-based classification algorithm. The dataset will be divided into separate training and testing subsets, with the training dataset used to develop the model and determine classification thresholds, and the independent testing dataset used to evaluate diagnostic performance. The model will generate a classification categorizing participants as "Positive for autism", "Intermediate" or "Negative for autims". Participants with intermediate results are considered to have indeterminate findings and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.
Studietyp
Observationell
Inskrivning (Beräknad)
1000
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Myrthe J. Ottenhoff, MD, PhD
- Telefonnummer: 908-824-3471
- E-post: study@blinklab.org
Studieorter
-
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New Jersey
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Princeton, New Jersey, Förenta staterna, 08540
- Rekrytering
- Remote study conducted nationwide; all participation occurs via smartphone app at home.
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Kontakt:
- Myrthe J. Ottenhoff, MD, PhD
- Telefonnummer: 908-824-3471
- E-post: study@blinklab.org
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Ja
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Children aged 2-11 years of which the parents/caregivers and/or pediatrician (or other primary care provider) have raised concerns regarding their neurodevelopment and have undergone neurodevelopmental assessment in the last 12 months that would allow diagnosing any neurodevelopmental condition according to DSM5 criteria.
Beskrivning
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:
- 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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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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.
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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.
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.
|
|
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.
|
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.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Sensitivity of BlinkLab Dx1
Tidsram: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Sensitivity of BlinkLab Dx1, defined as the proportion of participants with a positive clinical reference standard diagnosis of autism who are correctly identified as positive by the index test.
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Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
|
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Specificity of BlinkLab Dx1
Tidsram: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Specificity of the BlinkLab Dx1 algorithm, defined as the proportion of participants without a clinical reference standard diagnosis of autism who are correctly identified as negative by the index test.
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Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adverse Events
Tidsram: During individual enrollment period (up to 30 days)
|
A qualitative description of any adverse events that occurred during the study from the time of informed consent until the completion of the diagnostic evaluation.
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During individual enrollment period (up to 30 days)
|
|
Usability
Tidsram: During the individual enrollment period (up to 30 days)
|
The usability of the device for parents/caregivers in relation to the use-related risk analysis identified risks.
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During the individual enrollment period (up to 30 days)
|
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Autism Symptom Severity
Tidsram: Baseline (including neurodevelopmental assessment data from up to 12 months prior to enrollment and a single SRS-2 assessment collected once during the enrollment period [up to 30 days after enrollment])
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Based on prospectively collected SRS-2 questionnaire scores and retrospectively collected standardized autism assessment results documented in the neurodevelopmental assessment report.
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Baseline (including neurodevelopmental assessment data from up to 12 months prior to enrollment and a single SRS-2 assessment collected once during the enrollment period [up to 30 days after enrollment])
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Positive Predictive Value (PPV) of BlinkLab Dx1
Tidsram: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Positive predictive value, defined as the proportion of participants with a positive BlinkLab Dx1 test result who have a positive clinical reference standard diagnosis of autism.
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Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Negative Predictive Value of BlinkLab Dx1
Tidsram: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Negative predictive value, defined as the proportion of participants with a negative BlinkLab Dx1 test result who do not have a clinical reference standard diagnosis of autism.
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Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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False Positive Rate of BlinkLab Dx1
Tidsram: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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False positive rate, defined as the proportion of participants without a clinical reference standard diagnosis of autism who are incorrectly identified as positive by the BlinkLab Dx1 index test.
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Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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False Negative Rate of BlinkLab Dx1
Tidsram: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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False negative rate, defined as the proportion of participants with a clinical reference standard diagnosis of autism who are incorrectly identified as negative by the BlinkLab Dx1 index test.
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Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Accuracy of BlinkLab Dx1
Tidsram: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Accuracy, defined as the proportion of all participants who are correctly classified by the BlinkLab Dx1 index test (i.e., the sum of true positives and true negatives divided by the total number of participants), relative to the clinical reference standard diagnosis.
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Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Timing Task Performance
Tidsram: Single time point during enrollment period (up to 30 days after enrollment)
|
Performance on the BlinkLab timing task and its relation with ADHD symptom severity as measured with the modified Vanderbilt ADHD Diagnostic Parent Rating Scale (VADRS)
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Single time point during enrollment period (up to 30 days after enrollment)
|
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Go/No-Go Taks Performance
Tidsram: Single time point during enrollment period (up to 30 days after enrollment)
|
Performance on the Blinklab go/no-go task and its relation with ADHD symptom severity as measured with the VADRS.
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Single time point during enrollment period (up to 30 days after enrollment)
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Latency Task Performance
Tidsram: Single time point during enrollment period (up to 30 days after enrollment)
|
Performance on the Blinklab latency task and its relation with ADHD symptom severity as measured with the VADRS.
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Single time point during enrollment period (up to 30 days after enrollment)
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 februari 2025
Primärt slutförande (Beräknad)
1 september 2026
Avslutad studie (Beräknad)
1 december 2026
Studieregistreringsdatum
Först inskickad
11 maj 2026
Först inskickad som uppfyllde QC-kriterierna
11 maj 2026
Första postat (Faktisk)
15 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 08012025
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
BlinkLab is a publicly listed company holding patents related to the BlinkLab Dx technology.
The sponsor intends to evaluate mechanisms for sharing de-identified, non-proprietary participant-level data with qualified academic investigators under data use agreements that protect participant privacy and BlinkLab's intellectual property.
Any shared data will exclude raw video, audio, or algorithmic outputs that are proprietary or potentially identifiable.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
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Nej
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