Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus
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
- 否
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
