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临床试验/NCT02278848
NCT02278848已完成不适用

Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus

University Hospital, Tours2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2014年7月21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
39
试验地点
2
主要终点
Urinary incontinence

研究概览

简要总结

Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that ICAH is a classic, curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after CSF depletion. In consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression.

Over recent years, the cognitive profile of patients with ICAH has become better characterised and reproducible, objective techniques have been developed to assess motor function and CSF flow in the brain.

The investigators project aims to define the value of these new investigative techniques in the positive diagnosis of ICAH, in comparison to current decision-making tools.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Adult 65 years or older
  • Hospitalized patients (at the University Hospital of Tours) requiring the assessment of chronic hydrocephalus in adults, suspected clinically
  • Patient undergoing Lumbar Puncture subtractive
  • Informed consent form signed
  • Affiliated to a medical insurance

排除标准

  • Contraindications to MRI
  • Inability to walk or to stand before having lumbar puncture
  • Patient under trusteeship and guardianship, or judicial protection

结局指标

主要结局

Urinary incontinence

时间窗: 5 days

Association between the decision-making with regard to permanent CSF shunt and the Urinary incontinence scale

Computerised gait analysis

时间窗: 5 days

Association between the decision-making with regard to permanent CSF shunt and the Computerised gait analysis,

Ultrasound measurement of cerebral pulsatility

时间窗: 5 days

Association between the decision-making with regard to permanent CSF shunt and the Ultrasound measurement of cerebral pulsatility,

Cerebrospinal fluid biomarkers of degeneration from Alzheimer's disease.

时间窗: 5 days

Association between the decision-making with regard to permanent CSF shunt and the response to subtractive lumbar puncture

Qualitative and quantitative analysis (average speed and flow) of the hydrodynamic characteristics of the cerebrospinal fluid.

时间窗: 5 days

Association between the decision-making with regard to permanent CSF shunt and the MRI flow,

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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