Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Activation of the primary somatosensory cortex during stimulation omissions
研究概览
简要总结
A key function of our brain is to identify temporal structures in the environment and use them to form expectations. These expectations allow us to plan and organize our behavior towards changes in the environment, and optimize the use of our attentional and motor resources. They also allow us to establish harmonious social interactions, coordinating us with our interlocutor during an exchange. Our ability to form temporal expectations seems to emerge very early but the development of this process is unknown. We only know that a set of basic skills, probably related to that ability, are present from birth. This suggests that temporal processing capabilities emerge during the prenatal period, but this has not been studied. The objective of this project is to study preterm infants brain's ability to process the intervals between stimuli and to form expectations on that basis.
详细描述
40 patients (20 per group) : Presence of a functional response to stimulus omissions, only in the test group (regular presentation).
Group 1 will receive the test stimulation sequence (regular), Group 2 will receive the control stimulation sequence (random).
During the test sequence, a vibration will be repeated for 3 s interspersed with intervals of 5 s, creating an expectation about the presentation of the next stimulus. Every 8 to 12 vibrations (random), a vibration will be omitted. According to our hypothesis, we should observe an activity in the somatosensory cortex during the omission. A total of 10 omissions will be presented, bringing the total duration of stimulus presentation to 13 minutes.
During the control sequence, the interstimulus intervals are irregular, 3 to 7 seconds, so as not to induce expectations. Omissions in this case should not be associated with a functional brain response.
The presence of an activation in the primary somatosensory cortex will be assessed using Diffuse Correlation Spectroscopy (DCS), on newborns of 32, 33 and 35 weeks of corrected gestational age, during omissions in a regular vibrotactile stimulation sequence (test group) with respect to an irregular sequence (control group). A difference in activation during omissions between groups will reflect the presence of a processing of time intervals at the cortical level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- — 至 6 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40 premature infants born to SA 31 + 0 days to 32 weeks + 6 days , hospitalized in the neonatal unit of the University Hospital of Caen
排除标准
- •Suspected neurological disorder (grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia), or motor condition that might interfere with tactile perception on the hand
- •Intubation or CPAP
- •Viral of bacterial infection
- •Sedation at the time of measurement
- •Parent(s) who are minor or unable to give free and informed consent
- •No consent from the parents
- •Non-inclusion request by the child's neonatologist
研究组 & 干预措施
Test (Regular)
Regular stimulation sequence & DCS
干预措施: Regular stimulation sequence (Behavioral)
Control (Random)
Random stimulation sequence & DCS
干预措施: Random stimulation sequence (Behavioral)
Test (Regular)
Regular stimulation sequence & DCS
干预措施: DCS (Device)
Control (Random)
Random stimulation sequence & DCS
干预措施: DCS (Device)
结局指标
主要结局
Activation of the primary somatosensory cortex during stimulation omissions
时间窗: Between 32 and 35 week of corrected gestational age
次要结局
- Change in amplitude or time to peak of the response with age as a function of vigilance state(Between 32 and 35 week of corrected gestational age)
- Change in amplitude or time to peak of the response as a function of age(Between 32 and 35 week of corrected gestational age)