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NCT Number: NCT06497218

Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism

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.

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Key information

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammed VI National Center for the Disabled

Salé, Morocco

Location status: Recruiting

Location contact

Khalid Benhassan, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Blinklab diagnostic device

Diagnostic Test

Blinklab is a non-invasive diagnostic device for Autism Spectrum Disorder

Primary outcomes

  1. Device Sensitivity

    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

  2. Device Specificity

    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

Secondary outcomes

  1. Screen Avoidance

    Time frame: at baseline

    The percentage of trials wherein the child was avoiding the smartphone's screen and camera

  2. Anteroposterior Postural Stability

    Time frame: at baseline

    The child's anteroposterior postural stability

  3. Head Rotations

    Time frame: at baseline

    The percentage of trials wherein the child was rotating their head

  4. Headphone Touches

    Time frame: at baseline

    The percentage of trials wherein the child was touching the headphone

  5. Mouth Opening

    Time frame: at baseline

    The size and timing of the child's mouth openings and closings

  6. Vocalizations

    Time frame: at baseline

    The percentage of trials wherein the child was vocalizing and the corresponding time of occurrence

  7. Acoustic Startle Response (ASR)

    Time frame: at baseline

    Difference in the amplitude of the eyelid ASR between the ASD and neurotypical children

  8. Long-term habituation (long-term HAB)

    Time frame: at baseline

    Levels of habituation of the ASR over the course of the 15-minute test

  9. Prepulse inhibition (PPI)

    Time frame: at baseline

    Reduction in the amplitude of the eyelid startle response due to prepulse stimuli

  10. Short-term habituation (short-term HAB)

    Time frame: at baseline

    Habituation in the mean amplitude of eyelid startle responses over the course of the six startle pulses

  11. Anticipatory eye blinks (AEB)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Henk-Jan Boele, MD

CONTACT

[email protected]

+31611132247

Sponsors and collaborators

Lead sponsor

Blinklab Limited

Industry

Collaborators

  • Mohammed VI National Center for the Disabled, Salé, Morocco

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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