Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism

NCT ID: NCT06497218

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-01-15

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Blinklab diagnostic device

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Blinklab diagnostic device

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mohammed VI National Center for the Disabled, Salé, Morocco

UNKNOWN

Sponsor Role: collaborator

Blinklab Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mohammed VI National Center for the Disabled

Salé, , Morocco

Site Status: RECRUITING

Countries

Morocco

Central Contacts

Henk-Jan Boele, MD

Role: CONTACT

henkjan@blinklab.org

+31611132247

Facility Contacts

Khalid Benhassan, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 38129487 (View on PubMed)

Other Identifiers

13943

Identifier Type: -

Identifier Source: org_study_id