An interventional study of Blinklab diagnostic device in Autism Spectrum Disorder, sponsored by Blinklab Limited. Recruiting at 1 site in Morocco. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Blinklab Limited · Not applicable, Interventional, and Diagnostic
Retrospective case-control study to assess the diagnostic accuracy in autism spectrum disorder (ASD) of a new smartphone-based platform designed to conduct neurometric evaluations by measuring facial and behavioural reflexes.
This is a retrospective multi-centre case-control study to measure sensorimotor anomalies linked to autism spectrum disorder (ASD) to assess the diagnostic accuracy of smartphone-based neurobehavioral evaluations. The primary objective of the study is to evaluate diagnostic accuracy of the smartphone-based assessments compared to a formal clinical diagnosis using machine learning algorithms.
Neurobehavioral testing will be performed using BlinkLab, a smartphone-based platform. The tests include general measurement of spontaneous and stimulus-evoked postural, head, facial, and vocal responses along with specific neurometric tests, including the acoustically evoked eyelid startle reflex (ASR), and tests that involve the modulation of the ASR, including prepulse inhibition (PPI) and habituation (HAB). Children required to participate in two consecutive 15-minute tests. During the experiment, the children will watch an audio-normalized movie while the trials containing the auditory stimuli will be delivered via headphones. For each trial, computer vision algorithms will be used to track and record the position of the participant's facial landmarks over time. The study will compare responses in children with ASD who received a formal DSM-5 based diagnosis prior to study inclusion and neurotypical children that had no formal psychiatric diagnoses.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 450 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Blinklab Limited is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged between 3 and 12 years with Autism Spectrum Disorder who received a formal DSM-5 diagnosis will be tested with Blinklab smart phone based diagnostic tool
Diagnostic Test: Blinklab diagnostic device
Blinklab is a non-invasive diagnostic device for Autism Spectrum Disorder
Device Sensitivity
Measure of the proportion of children truly having ASD who are correctly identified by the device as Positive for ASD relative to a formal DSM-5 diagnosis
Time frame: at baseline
Device Specificity
Measure of the proportion of children truly not having ASD (who had no prior psychiatric diagnosis) who are correctly identified by the device as Negative for ASD
Time frame: at baseline
Screen Avoidance
The percentage of trials wherein the child was avoiding the smartphone's screen and camera
Time frame: at baseline
Anteroposterior Postural Stability
The child's anteroposterior postural stability
Time frame: at baseline
Head Rotations
The percentage of trials wherein the child was rotating their head
Time frame: at baseline
Headphone Touches
The percentage of trials wherein the child was touching the headphone
Time frame: at baseline
Mouth Opening
The size and timing of the child's mouth openings and closings
Time frame: at baseline
Vocalizations
The percentage of trials wherein the child was vocalizing and the corresponding time of occurrence
Time frame: at baseline
Acoustic Startle Response (ASR)
Difference in the amplitude of the eyelid ASR between the ASD and neurotypical children
Time frame: at baseline
Long-term habituation (long-term HAB)
Levels of habituation of the ASR over the course of the 15-minute test
Time frame: at baseline
Prepulse inhibition (PPI)
Reduction in the amplitude of the eyelid startle response due to prepulse stimuli
Time frame: at baseline
Short-term habituation (short-term HAB)
Habituation in the mean amplitude of eyelid startle responses over the course of the six startle pulses
Time frame: at baseline
Anticipatory eye blinks (AEB)
The anticipatory eye blinks (AEB) in predefined observation windows (OW) containing an omitted pulse. AEB were responses that were not triggered by the startle stimulus itself but rather by the expectation of an upcoming startle stimulus
Time frame: at baseline
Plan to share: No
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