Deciphering Brain Olfactory Pathways in Prader-Willi Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- hyperactivation of the right amygdala in young children with PWS not early OT-exposed and aged between 5 and 7 years in response to a sweet food odor compared to a neutral non-food odor.
研究概览
简要总结
Studying the cerebral activity of children with Prader-Willi Syndrom (PWS) when the study propose to them nasal activations.
详细描述
The present study propose to implement fMRI and olfactory tests to describe olfactory brain activation and olfactory skills in early OT-exposed and non-exposed children with PWS.
This study is part of a wider project in collaboration with the team of S. Steculorum at the Max Planck Institute in Germany who assess the architectural and molecular characterization of the olfactory system development in a mice model of PWS and the role of early OT treatment.
Moreover, the study will take advantage of the MRI to document the long-term brain connectivity of early OT-exposed and non-exposed children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child with a genetically confirmed diagnosis of PWS and for whom the genetic subtype (deletion or non deletion) has been identified
- •Child aged between 5 and 7 years
- •Child with a planned hospitalization at the Toulouse reference center for PWS
排除标准
- •Presence of a contraindication to MRI
- •Allergy to any of the fragrances used in the olfactory test
- •Presence of an ENT infection such as rhinitis or sinusitis on the day of inclusion
- •Reported anosmia
- •Administrative problems.
结局指标
主要结局
hyperactivation of the right amygdala in young children with PWS not early OT-exposed and aged between 5 and 7 years in response to a sweet food odor compared to a neutral non-food odor.
时间窗: day 1
intensity of right amygdala in fMRI
次要结局
- hyperactivation of the right amygdala in PWS children stimulated by a sweet food odor vs. a non-food odor compared to non-exposed children.(day 1)
- composite outcome witn an association between olfactory fMRI results and eating behavior in early OT-exposed and non-exposed children with PWS.(day 1)
- olfactory skills in early OT-exposed and non-exposed children with PWS.(Day 1)
- resting brain connectivity in early OT-exposed and non-exposed children with PWS.(day 1)