Electrophysiological Markers in Language and Learning Impairment: Early Intervention and Long-term Follow-up
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Electrophysiological markers in a task tapping neural entrainment administered at age 18 months.
研究概览
简要总结
The present project develops from a wide research line aiming at identifying very early electrophysiological risk markers for neurodevelopmental disorders. Long-term goals of the study include the characterization of language/learning developmental trajectories in children at high risk for language disorders and the implementation of ecological interventions based on enriched auditory experience to be employed to these children in an attempt to modify their atypical developmental trajectory before the emergence and crystallization of any behavioural symptoms and within the early period of known maximum cerebral plasticity.
Specifically, the main aim of this study is the development and implementation of an innovative and ecological early intervention based on environmental auditory enrichment (labelled "rhythmic intervention"). This intervention is tested both on a sample of typically developing infants and on a sample of infants at high familial risk for language disorders during a time span between 7 and 9 months of age. The efficacy of the intervention is tested on the electrophysiological markers tested before and after the intervention activities and on the linguistic outcomes within a longitudinal approach. The efficacy of such an intervention is compared to the spontaneous development observed in comparable groups of infants with and without familial risk for language disorders. In addition, only in a group of typically developing infants, a control intervention providing passive exposure to the same auditory stimulation is tested, in order to verify the specific contribution of the active participation of the children to the intervention.
The investigators hypothesize that the rhythmic intervention may modify the electrophysiological markers underlying auditory processing and the linguistic skills of all children, with a larger increase in infants at familial risk for language disorders who are specifically impaired in such skills.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants aged between 6 and 9 months
- •Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders.
- •Both parents are native-Italian speakers
排除标准
- •Gestational age < 37 weeks and/or birth-weight < 2500 grams
- •APGAR scores at birth at 1' and 5' < 7
- •Bayley Cognitive Score < 7
- •Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders or autism within first-degree relatives.
结局指标
主要结局
Electrophysiological markers in a task tapping neural entrainment administered at age 18 months.
时间窗: Age 18 months.
Early neural mechanisms supporting speech and acoustic perception are recorded in response to non-speech and speech rhythmic stimuli modulated at different rates. Neural entrainment to the incoming rhythms is measured in the form of peaks emerging from the EEG spectrum at frequencies corresponding to the rhythm envelope.
Electrophysiological markers (Mismatch Response) in a non-speech multi-feature oddball paradigm administered at age 24 months.
时间窗: Age 24 months
In the non-speech multi-feature paradigm, pairs of complex tones are presented at a rapid rate (70ms inter-stimulus interval) and stimuli differing in either frequency or duration serve as deviants. Mean amplitude of the MisMatch Response is computed.
Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 12 months.
时间窗: Age 12 months
In the non-speech multi-feature paradigm, pairs of complex tones are presented at a rapid rate (70ms inter-stimulus interval) and stimuli differing in either frequency or duration serve as deviants. Latency of the obligatory peak (P1/P2) are computed.
Electrophysiological markers (MisMatch Response) in a non-speech multi-feature oddball paradigm administered at age 12 months.
时间窗: Age 12 months
In the non-speech multi-feature paradigm, pairs of complex tones are presented at a rapid rate (70ms inter-stimulus interval) and stimuli differing in either frequency or duration serve as deviants. Mean amplitude of the MisMatch Response is computed.
Electrophysiological markers in a task tapping neural entrainment administered immediately after the end on the intervention (or at comparable age).
时间窗: Age 10-11 months.
Early neural mechanisms supporting speech and acoustic perception are recorded in response to non-speech and speech rhythmic stimuli modulated at different rates. Neural entrainment to the incoming rhythms is measured in the form of peaks emerging from the EEG spectrum at frequencies corresponding to the rhythm envelope.
Electrophysiological markers (obligatory peak) in a non-speech multi-feature oddball paradigm administered at age 24 months.
时间窗: Age 24 months
In the non-speech multi-feature paradigm, pairs of complex tones are presented at a rapid rate (70ms inter-stimulus interval) and stimuli differing in either frequency or duration serve as deviants. Latency of the obligatory peak (P1/P2) are computed.
次要结局
- Receptive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.(Age 24 months)
- Expressive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.(Age 12 months)
- Expressive vocabulary at age 24 months assessed through the Language Development Survey(Age 24 months)
- Expressive Language at age 24 months assessed through the Bayley Scales of Infant and Toddler Development.(Age 24 months)
- Receptive Language at age 12 months assessed through the Bayley Scales of Infant and Toddler Development.(Age 12 months)
- Expressive vocabulary at age 20 months assessed through the Language Development Survey(Age 20 months)
- Mean Length Utterance assessed through the Language Development Survey(Age 24 months)
- Receptive vocabulary assessed through the Picture Naming Game.(Age 20 months)