Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
- Conditions
- Autism Spectrum Disorder
- Interventions
- Diagnostic Test: Blinklab diagnostic device
- Registration Number
- NCT06497218
- Lead Sponsor
- Blinklab Limited
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- Male or female individuals between the ages of 3 - 12 years old at the time of consent.
- Caregiver must be able to read, understand and sign the Informed Consent Form (ICF).
- Normal or corrected-to-normal vision with visual acuity sufficient to watch short videos.
- Hearing adequate to hear the auditory stimuli delivered via headphones.
- Participants under 3 or over 12 years old.
- Severe hearing or visual impairment.
- Participants using medication that affects the nervous system (classified as ATC N0 medication, https://www.whocc.no).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Children formally diagnosed with Autism Spectrum Disorder Blinklab diagnostic device 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
- Primary Outcome Measures
Name Time Method Device Sensitivity 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
Device Specificity 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
- Secondary Outcome Measures
Name Time Method Headphone Touches at baseline The percentage of trials wherein the child was touching the headphone
Mouth Opening at baseline The size and timing of the child's mouth openings and closings
Vocalizations at baseline The percentage of trials wherein the child was vocalizing and the corresponding time of occurrence
Short-term habituation (short-term HAB) at baseline Habituation in the mean amplitude of eyelid startle responses over the course of the six startle pulses
Prepulse inhibition (PPI) at baseline Reduction in the amplitude of the eyelid startle response due to prepulse stimuli
Head Rotations at baseline The percentage of trials wherein the child was rotating their head
Acoustic Startle Response (ASR) at baseline Difference in the amplitude of the eyelid ASR between the ASD and neurotypical children
Long-term habituation (long-term HAB) at baseline Levels of habituation of the ASR over the course of the 15-minute test
Screen Avoidance at baseline The percentage of trials wherein the child was avoiding the smartphone's screen and camera
Anteroposterior Postural Stability at baseline The child's anteroposterior postural stability
Anticipatory eye blinks (AEB) 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
Trial Locations
- Locations (1)
Mohammed VI National Center for the Disabled
🇲🇦Sale, Morocco