Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism

Blinklab Limited

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Diagnostic Test: Blinklab diagnostic device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06497218

13943

Details and patient eligibility

About

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.

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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450 participants in 1 patient group

Children formally diagnosed with Autism Spectrum Disorder

Experimental group

Description:

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

Treatment:

Diagnostic Test: Blinklab diagnostic device