Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497218
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-04
Brief Title:
Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
Sponsor:
Blinklab Limited
Organization:
Blinklab Limited
Study Overview
Official Title:
Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 participants 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
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 participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None