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临床试验/NCT05068128
NCT05068128已完成不适用

Combined Flow-pressure Study of Cerebrospinal Circulation Using CSF Perfusion Tests and Phase-contrast MRI - Reversible Dementia Substudy

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Variation of number of MRICP parameters according of CSF accumulation

研究概览

简要总结

Normal pressure hydrocephalus (NPH) can cause a type of dementia. However, this type of dementia is the only one that is reversible. To treat this dementia it is necessary to evacuate the accumulation of CSF from the brain to another body cavity using a device called a shunt. But the implantation of this shunt is only effective when the cause of the pathology is an alteration of the normal circulation of the CSF. To diagnose these patients, morphological MRI and lumbar puncture are standard approaches used but remain perfectible in diagnostic terms.

The main objective is to build a new model of the interaction of intracranial pressures and fluids in order to obtain a new parameter allowing to obtain information on the cerebral biomechanics.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age > 55 years
  • Patients with suspected active hydrocephalus (HA) known as "normal pressure":
  • Ventricular dilatation: Evans index > 0.3
  • Patients with cognitive impairment, and/or gait disorders and/or urinary incontinence or a combination of these three symptoms.
  • Absence of other neurological diseases that could cause ventriculomegaly.
  • Information and collection of the patient's non opposition

排除标准

  • All patients with neurological disease other than active hydrocephalus will be excluded.
  • Individuals who cannot tolerate an MRI examination
  • All individuals with implants, pacemakers, prostheses and ferromagnetic objects
  • Patients under guardianship, curators or safeguard of justice

结局指标

主要结局

Variation of number of MRICP parameters according of CSF accumulation

时间窗: up to 3 years

The MRICP parameter will combine the CSF pressure and CSF flows. MRICP parameter results of the interaction of intracranial pressures and fluids in order allowing to obtain information on the cerebral biomechanics. Accumulation of CSF from the brain to another body cavity is neccessary to be determined.

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 (2)

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