Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
11 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
1000
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Myrthe J. Ottenhoff, MD, PhD
- Número de teléfono: 908-824-3471
- Correo electrónico: study@blinklab.org
Ubicaciones de estudio
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New Jersey
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Princeton, New Jersey, Estados Unidos, 08540
- Reclutamiento
- Remote study conducted nationwide; all participation occurs via smartphone app at home.
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Contacto:
- Myrthe J. Ottenhoff, MD, PhD
- Número de teléfono: 908-824-3471
- Correo electrónico: study@blinklab.org
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Sensitivity of BlinkLab Dx1
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adverse Events
Periodo de tiempo: 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)
|
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Usability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
|
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
Periodo de tiempo: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
|
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)
|
|
False Positive Rate of BlinkLab Dx1
Periodo de tiempo: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
|
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
Periodo de tiempo: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
|
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
Periodo de tiempo: Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)
|
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.
|
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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Timing Task Performance
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Single time point during enrollment period (up to 30 days after enrollment)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de febrero de 2025
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
- Autismo
- Estudio observacional
- Desorden del espectro autista
- Salud digital
- Aplicación movil
- Movimientos oculares
- Aprendizaje automático
- Diagnóstico de autismo
- Evaluación Digital
- Neurodevelopmental Conditions
- Pediatric Assessment
- Smartphone-based Assessment
- Remote Study
- Repetitive Behavior
- Reflexive Sensorimotor Behavior
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 08012025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .