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Actively Recruiting

Phase Not Applicable
Age: 3Years - 12Years
All Genders
Healthy Volunteers
ID06497218

Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism

Led by Blinklab Limited · Updated on 2024-07-12

450

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

B

Blinklab Limited

Lead Sponsor

M

Mohammed VI National Center for the Disabled, Salé, Morocco

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a smartphone-based platform called BlinkLab to assist in diagnosing Autism Spectrum Disorder ASD by measuring facial and behavioral reflexes. This retrospective multi-center case-control study aims to determine how accurately these smartphone-based neurobehavioral tests can identify ASD compared to formal clinical diagnoses using machine learning. The study includes children with ASD and neurotypical children without psychiatric diagnoses to compare sensorimotor responses. The neurobehavioral evaluations involve two consecutive 15-minute tests where children watch an audio-normalized movie while auditory stimuli are delivered through headphones. BlinkLab measures spontaneous and stimulus-evoked postural, head, facial, and vocal responses, including specific reflex tests like the acoustically evoked eyelid startle reflex ASR, prepulse inhibition PPI, and habituation HAB. Facial landmarks are tracked using computer vision algorithms to record the childrens responses during each trial. Participants are children aged 3 to 12 years who undergo these non-invasive assessments. Researchers measure various outcomes such as device sensitivity and specificity, screen avoidance, postural stability, head rotations, mouth opening, vocalizations, and acoustic startle responses. The study collects detailed behavioral and neurometric data to evaluate the diagnostic accuracy of the smartphone-based tool. The total participation involves completing the two testing sessions under standardized conditions, with no treatment or medication changes involved.

CONDITIONS

Brief Title

Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism

Who Can Participate

Age: 3Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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).

Research Team

H

Henk-Jan Boele, MD

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