Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Device Sensitivity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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
干预措施: Blinklab diagnostic device (Diagnostic Test)
结局指标
主要结局
Device Sensitivity
时间窗: at baseline
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
Device Specificity
时间窗: at baseline
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
次要结局
- Headphone Touches(at baseline)
- Prepulse inhibition (PPI)(at baseline)
- Mouth Opening(at baseline)
- Vocalizations(at baseline)
- Short-term habituation (short-term HAB)(at baseline)
- Head Rotations(at baseline)
- Acoustic Startle Response (ASR)(at baseline)
- Long-term habituation (long-term HAB)(at baseline)
- Screen Avoidance(at baseline)
- Anteroposterior Postural Stability(at baseline)
- Anticipatory eye blinks (AEB)(at baseline)