Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism

NCT06497218 | Recruiting

• 1 other identifier: 13943
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Screen Avoidance

  at baseline

• Anteroposterior Postural Stability

  at baseline

• Head Rotations

  at baseline

• Headphone Touches

  at baseline

• Mouth Opening

  at baseline

Study Arms (1)

Children formally diagnosed with Autism Spectrum Disorder

EXPERIMENTAL

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

Interventions

Blinklab diagnostic device DIAGNOSTIC_TEST

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

Children formally diagnosed with Autism Spectrum Disorder

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Blinklab Limited: lead
• Mohammed VI National Center for the Disabled, Salé, Morocco: collaborator

Study Sites (1)

Mohammed VI National Center for the Disabled

Salé, Morocco

RECRUITING

Related Publications (1)

• 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.

  PMID: 38129487 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Henk-Jan Boele, MD

CONTACT

+31611132247; henkjan@blinklab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All subjects will undergo investigational diagnosis for ASD. Results will be compared to formal diagnosis by healthcare specialists.

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: May 15, 2023
• Primary Completion: October 16, 2024
• Study Completion: January 15, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)