跳至主要内容
临床试验/NCT05915000
NCT05915000招募中不适用

Alterations of CSF Protein Markers as Prognostic Indicator of the Response to Cerebrospinal Fluid Shunting in Chronic Hydrocephalus in Adults

University of Valencia4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年6月13日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
4
主要终点
Correlation between lumbar CSF protein markers and response to CSF shunt in normal pressure hydrocephalus

研究概览

简要总结

In all published series of adult chronic hydrocephalus, there is a percentage between twenty and twenty-five percent of patients who present poor results after implantation of a cerebrospinal fluid shunt,1-11 usually ventriculoperitoneal. The lumboperitoneal shunt is also used but much more rarely.

The diagnosis of this pathology is based on the clinical picture, neuroimaging studies (Evans index and corpus callosum angle), cerebrospinal fluid dynamics tests (Katzman test), and invasive intracranial pressure measurements. Despite all this diagnostic arsenal, there is a high percentage of patients (mentioned above) in which treatment by diversion of cerebrospinal fluid does not offer the expected results. Traditionally, this has been attributed to chronic adult hydrocephalus being associated with other types of dementia. This may be the case in some patients, and it would be important to predict which patients will not improve or who will improve poorly in the case of insertion of a cerebrospinal fluid shunt.

详细描述

Adult chronic hydrocephalus, also known as normal pressure hydrocephalus or normal pressure hydrocephalus, presents with the classic Hakim-Adams triad, gait ataxia or "magnetic gait", urinary incontinence, and dementia.

Most cases have an idiopathic origin and constitute the only potentially reversible cause of dementia with surgical treatment (using a system for shunting the cerebrospinal fluid or CSF from the lateral ventricles or the thecal sac to the peritoneal cavity or right atrium ), so it is especially important to diagnose and treat it properly.

The prevalence of this pathology is increasing in line with the increase in the life expectancy of the population.

The diagnosis of this pathology is based on the clinical features, neuroimaging studies (CT and Magnetic Resonance), cerebrospinal fluid dynamics tests (Katzman test), cerebrospinal fluid drainage by lumbar puncture or using lumbar drainage for hours, and invasive measurements of Intracranial Pressure (ICP). Continuous monitoring of Intracranial Pressure with the patient admitted for 3-5 days (continuously night and day) is the most sensitive and specific diagnostic method for this disease, but it also has its false positives and negatives. Likewise, even though complications are very infrequent, it is an invasive technique that requires prolonged and continuous recordings to assess hydrodynamic changes.

Unfortunately, and despite all the diagnostic arsenal, the results of treatment using cerebrospinal fluid shunts (lumboperitoneal or ventriculoperitoneal), even in the best series, yield 20-25% poor results. These poor results have been attributed to many factors, including associated cerebral vascular disease problems, coexisting dementia not always well diagnosed, and Parkinson's disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Minimum age of 18 years, there is no maximum age, especially if it is understood that this pathology is more frequent as one advance in age, especially among males; pathology compatible with chronic adult hydrocephalus

排除标准

  • All patients whose suspected diagnosis is not adult chronic hydrocephalus will be excluded, specifically those with cerebrovascular disease, dementia not due to adult chronic hydrocephalus, Alzheimer's disease, Parkinson's disease, and hereditary degenerative brain pathology. Huntington's chorea

结局指标

主要结局

Correlation between lumbar CSF protein markers and response to CSF shunt in normal pressure hydrocephalus

时间窗: 1 year

To try to establish the positive correlation between the abnormal levels in cerebrospinal fluid of the proteins beta 1-42 amyloid, h-tau and phospho-tau and the clinical outcome before the implantation of a cerebrospinal fluid shunt system.

Lumbar CSF protein marker levels that recommend no CSF shunt in normal pressure hydrocephalus

时间窗: 1 year

If there is a positive correlation, determine which would be the abnormal levels in the cerebrospinal fluid of the proteins β1-42 amyloid, h-tau and phospho-tau in the event of which a cerebrospinal fluid shunt system should not be implanted

Correlation Between CSF Amyloid β1-42 Level and Shunt Response

时间窗: 1 year

Correlation between lumbar CSF Amyloid β1-42 concentration and clinical outcome following CSF shunting. Unit of Measure: pg/mL

Correlation Between CSF Total Tau (h-tau) Level and Shunt Response

时间窗: 1 year

Correlation between lumbar CSF total tau concentration and clinical outcome following CSF shunting. Unit of Measure: pg/mL

Correlation Between CSF Phospho-Tau Level and Shunt Response

时间窗: 1 year

Correlation between lumbar CSF phospho-tau concentration and clinical outcome following CSF shunting. Unit of Measure: pg/mL

Threshold Levels of CSF Biomarkers Associated With Poor Shunt Response

时间窗: 1 year

Identification of cutoff values of CSF β1-42 amyloid, total tau, and phospho-tau associated with poor clinical response after CSF shunting. Unit of Measure: pg/mL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vicente Vanaclocha

Professor

University of Valencia

研究点 (4)

Loading locations...

相似试验