Mohammed VI National Center for the Disabled
Salé, Morocco
Location status: Recruiting
Location contact
Khalid Benhassan, MD
CONTACT
NCT Number: NCT06497218
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.
Interested in participating?
Request Info3 year–12 year
All sexes
Interventional
Not applicable
Salé, Morocco
Location status: Recruiting
Khalid Benhassan, MD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Blinklab is a non-invasive diagnostic device for Autism Spectrum Disorder
Time frame: at baseline
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
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
The percentage of trials wherein the child was avoiding the smartphone's screen and camera
Time frame: at baseline
The child's anteroposterior postural stability
Time frame: at baseline
The percentage of trials wherein the child was rotating their head
Time frame: at baseline
The percentage of trials wherein the child was touching the headphone
Time frame: at baseline
The size and timing of the child's mouth openings and closings
Time frame: at baseline
The percentage of trials wherein the child was vocalizing and the corresponding time of occurrence
Time frame: at baseline
Difference in the amplitude of the eyelid ASR between the ASD and neurotypical children
Time frame: at baseline
Levels of habituation of the ASR over the course of the 15-minute test
Time frame: at baseline
Reduction in the amplitude of the eyelid startle response due to prepulse stimuli
Time frame: at baseline
Habituation in the mean amplitude of eyelid startle responses over the course of the six startle pulses
Time frame: at baseline
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
Contact information is provided by the study sponsor or research team.
Blinklab Limited
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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