Individual Neurophysiological Sensory Profiles in People With and Without Neurodevelopmental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Amplitude of central neurophysiological responses to sensory stimulations
研究概览
简要总结
The goal of this observational study is to evaluate intra-individual neurophysiological variability in children and adults with and without NeuroDevelopmental Disorders (NDD), for several sensory modalities and types of stimulation. The main hypotheses are:
- NDD participants and children exhibit higher intra-individual variability than other participants
- intra-individual neurophysiological variability is correlated to behavioral, psychological and learning profiles
Participants in this study will:
- be recorded for EEG and other neurophysiological parameters while exposed to sensory stimulations, to quantify sensory neurophysiological variability
- perform behavioral tests and fill out questionnaires, to establish the behavioral and psychological profile
- train for perceptual learning, to measure learning abilities
These evaluations will be split in 3 visits spread on a maximum of 3 months, and training for learning will be done at home in between 2 visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Social security affiliation
- •Free and written informed consent from the participants (Neurotypical Adults, NDD Adults without judicial protective measures), or their tutor or legal representant(s) (other participants)
- •Age between 6 and 12 years included (Children) or between 18 and 45 years included (Adults)
- •For NDD participants: NDD diagnosis by a qualified medical professional, according to DSM-4, DSM-5, ICD-10 or ICD-11 criteria
- •Non-inclusion Criteria:
- •Psychotropic medication perturbing EEG recording
- •Drugs pertubing peripheral neurophysiological measures
- •Non-corrected visual or auditory troubles
- •Known neurological or psychiatric conditions (at the exclusion of NDD for NDD participants)
- •Inclusion in another ongoing medical protocol
- •For Neurotypical participants: NDD diagnosis
- •For NDD participants: anticipated psychological or physical risk at participating, at the investigator's discretion
排除标准
- •Participants with no data to evaluate Outcome 1
研究组 & 干预措施
Neurotypical Adults
18-45 years old adults
Neurodevelopmental Disorders Children
6-12 years old children
Neurodevelopmental Disorders Adults
18-45 years old adults
Neurotypical Children
6-12 years old children
结局指标
主要结局
Amplitude of central neurophysiological responses to sensory stimulations
时间窗: Through study completion, an average of 2 months per participant
Amplitude (in micro-volts) of event-related potentials
Latency of central neurophysiological responses to sensory stimulations
时间窗: Through study completion, an average of 2 months per participant
Latency (in milli-seconds) of event-related potentials
Variability of central neurophysiological responses to sensory stimulations
时间窗: Through study completion, an average of 2 months per participant
Intra-individual variability (in percentage) of event-related potentials
次要结局
- Visual perceptual learning performance(Through study completion, an average of 2 months per participant)
- Auditory perceptual learning performance(Through study completion, an average of 2 months per participant)
- Behavioral sensory profile(Through study completion, an average of 2 months per participant)
- Sensory profile questionnaire(Through study completion, an average of 2 months per participant)
- Cognitive psychological profile(Through study completion, an average of 2 months per participant)
- Executive functions questionnaire(Through study completion, an average of 2 months per participant)
- Attentional functions questionnaire(Through study completion, an average of 2 months per participant)
- Socio-emotional questionnaire(Through study completion, an average of 2 months per participant)
- Linguistic profile(Through study completion, an average of 2 months per participant)
- Heart beat response to sensory stimulations(Through study completion, an average of 2 months per participant)
- Electrodermal activity response to sensory stimulations(Through study completion, an average of 2 months per participant)
- Pupillary response to sensory stimulations(Through study completion, an average of 2 months per participant)