Alterations of CSF Protein Markers as Prognostic Indicator of the Response to Cerebrospinal Fluid Shunting in Chronic Hydrocephalus in Adults
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
- 否
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
Vicente Vanaclocha
Professor
University of Valencia
