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临床试验/NCT06502431
NCT06502431招募中不适用

Analysis of Disturbances in Neurofluid Dynamics in Type I Chiari Malformations

Centre Hospitalier Universitaire, Amiens3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
3
主要终点
CSF Flow

研究概览

简要总结

A global analysis of craniospinal hemodynamics and hydrodynamics is necessary to better understand the pathophysiology of Chiari malformations. This includes an analysis of intraventricular CSF flow, intracranial subarachnoid spaces, foramen magnum, cervical subarachnoid spaces and within the syringomyelia cavity when present. The investigators will also analyze the pulsatility of the cerebellar tonsils in the foramen magnum. Hemodynamic analysis will be performed at the high cervical level (internal carotid and vertebral arteries, jugular veins) and intracranially (carotid and basilar arteries, right sinus and superior longitudinal sinus). This analysis will be made possible by PCMRI acquisitions with slice planes allowing the analysis of the dynamics of the CSF (mesencephalic aqueduct, prepontic cisterns, foramen magnum, at the level of the C2C3 disc, syringomyelia if present), cerebellar tonsils (foramen magnum). The cross-sectional planes for hemodynamic analysis will be at the level of the C2C3 disc (cervical vascular analysis) and upstream of the polygon of Willis (intracranial vascular analysis).

The goal is to complement the clinical and morphological investigations with quantitative imaging of cerebrospinal fluid (CSF) and blood flow in the craniospinal system. These flows are potentially altered or causes of this Chiari anomaly.

The investigators propose a translational research project of clinical research allowing the analysis of a diagnostic technique by a diagnostic, monocentric, prospective study. After neurosurgical consultation, patients with Chiari malformation will be assigned to a symptomatic Chiari malformation or a non-symptomatic Chiari malformation group. They will be offered to participate in this study after information and informed consent. The allocation between the two groups will be made according to the symptomatic or non-symptomatic nature of the Chiari malformation. After inclusion, the patients will have a morphological MRI and a PCMRI according to the determined slice plans and allowing a global analysis of the craniospinal hemohydrodynamics. Craniospinal hemohydrodynamics in a control population will also be analyzed using the same methodology by PCMRI.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with major symptomatic or nonsymptomatic CMI
  • aged 18 to 50 years
  • no previous neurosurgical, neurological, or cardiological history.
  • Controls should be age-matched to symptomatic CMI group. They should not have a history of neurosurgery, neurology, or cardiology.

排除标准

  • Patients who are minors or over 50 years of age
  • CMI invalidated by our radiological review
  • Neurosurgical, neurological or cardiological history
  • MRI contraindication
  • pregnant, breast-feeding and parturient women

研究组 & 干预措施

Symptomatic CMI group

Experimental

干预措施: phase contrast sequences (Other)

Non-Symptomatic CMI group

Experimental

干预措施: phase contrast sequences (Other)

Control group

Active Comparator

干预措施: phase contrast sequences (Other)

结局指标

主要结局

CSF Flow

时间窗: day 1

Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.

Blood Flow

时间窗: day 1

Flow will be measured by the oscillatory volume expressed in mL/cardiac cycle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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