Clinical trial NCT06497218: Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
Official title: Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Blinklab Limited
Sponsor class: INDUSTRY
Collaborators: name: Mohammed VI National Center for the Disabled, Salé, Morocco
First posted: 2024-07-11
Enrollment: 450
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will undergo investigational diagnosis for ASD. Results will be compared to formal diagnosis by healthcare specialists.
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: Device Sensitivity
timeFrame: at baseline
measure: Device Specificity
timeFrame: at baseline
Secondary outcomes:
measure: Screen Avoidance
timeFrame: at baseline
measure: Anteroposterior Postural Stability
timeFrame: at baseline
measure: Head Rotations
timeFrame: at baseline
measure: Headphone Touches
timeFrame: at baseline
measure: Mouth Opening
timeFrame: at baseline
measure: Vocalizations
timeFrame: at baseline
measure: Acoustic Startle Response (ASR)
timeFrame: at baseline
measure: Long-term habituation (long-term HAB)
timeFrame: at baseline
measure: Prepulse inhibition (PPI)
timeFrame: at baseline
measure: Short-term habituation (short-term HAB)
timeFrame: at baseline
measure: Anticipatory eye blinks (AEB)
timeFrame: at baseline
Other outcomes:
Locations:
city: Sale
country: Morocco
facility: Mohammed VI National Center for the Disabled
Study officials:
References:
citation: 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.