Health Trials

Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism

ConditionAutism Spectrum Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorBlinklab Limited

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • Blinklab diagnostic device

    Diagnostic test

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

Treatment groups

450 Participants
are divided into 1 treatment group
Group A: Children formally diagnosed with Autism Spectrum DisorderExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Screen Avoidance

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

Time frame
at baseline
2

Anteroposterior Postural Stability

The child's anteroposterior postural stability

Time frame
at baseline
3

Head Rotations

The percentage of trials wherein the child was rotating their head

Time frame
at baseline
4

Headphone Touches

The percentage of trials wherein the child was touching the headphone

Time frame
at baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blinklab Limited

Lead sponsor

Mohammed VI National Center for the Disabled, Salé, Morocco

Collaborator

Source ClinicalTrials.gov
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