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.

Study Overview

• Status: Recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Diagnostic test: Blinklab diagnostic device

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.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Henk-Jan Boele, MD; Phone Number: +31611132247; Email: henkjan@blinklab.org

Study Locations

• Morocco
  • Sale, Morocco
    • Recruiting
    • Mohammed VI National Center for the Disabled
    • Contact: Khalid Benhassan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Study Population

Male or female individuals between the ages of 3 - 12 years old at the time of consent for whom the autism diagnosis established by a multidisciplinary team of specialists using the Diagnostic and Statistical Manual of Mental Disorders criteria prior to recruitment or neurotypical children who has no formal psychiatric diagnoses.

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children formally diagnosed with Autism Spectrum Disorder; 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	Diagnostic test: Blinklab diagnostic device; Blinklab is a non-invasive diagnostic device for Autism Spectrum Disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline
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	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Screen Avoidance	The percentage of trials wherein the child was avoiding the smartphone's screen and camera	at baseline
Anteroposterior Postural Stability	The child's anteroposterior postural stability	at baseline
Head Rotations	The percentage of trials wherein the child was rotating their head	at baseline
Headphone Touches	The percentage of trials wherein the child was touching the headphone	at baseline
Mouth Opening	The size and timing of the child's mouth openings and closings	at baseline
Vocalizations	The percentage of trials wherein the child was vocalizing and the corresponding time of occurrence	at baseline
Acoustic Startle Response (ASR)	Difference in the amplitude of the eyelid ASR between the ASD and neurotypical children	at baseline
Long-term habituation (long-term HAB)	Levels of habituation of the ASR over the course of the 15-minute test	at baseline
Prepulse inhibition (PPI)	Reduction in the amplitude of the eyelid startle response due to prepulse stimuli	at baseline
Short-term habituation (short-term HAB)	Habituation in the mean amplitude of eyelid startle responses over the course of the six startle pulses	at baseline
Anticipatory eye blinks (AEB)	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	at baseline

Collaborators and Investigators

• Sponsor: Blinklab Limited
• Collaborators: Mohammed VI National Center for the Disabled, Salé, Morocco

Publications and helpful links

General Publications

• Boele HJ, Jung C, Sherry S, Roggeveen LEM, Dijkhuizen S, Ohman J, Abraham E, Uvarov A, Boele CP, Gultig K, Rasmussen A, Vinueza-Veloz MF, Medina JF, Koekkoek SKE, De Zeeuw CI, Wang SS. Accessible and reliable neurometric testing in humans using a smartphone platform. Sci Rep. 2023 Dec 18;13(1):22871. doi: 10.1038/s41598-023-49568-2.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): October 16, 2024
• Study Completion (Estimated): January 15, 2025

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 10, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 13943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No