Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Evans Ratio
研究概览
简要总结
The research project is designed to determine which combination of tests will enable physicians to predict whether a patient with symptoms of normal pressure hydrocephalus (NPH) will improve with a shunt.
详细描述
Normal pressure hydrocephalus (NPH) is a potentially reversible progressive neurological condition disproportionately affecting the elderly population. Given current controversies regarding its exact definition, accurate incidence and prevalence figures are elusive. NPH was first described forty years ago as a triad of symptoms consisting of gait difficulties, urinary incontinence, and memory problems in patients with enlarged ventricles in the absence of increased intracranial pressure (ICP). The cause of primary, or idiopathic NPH (INPH) remains elusive, while secondary NPH results from intracranial insults such as head trauma, meningitis, or intracranial hemorrhage. NPH can be successfully treated with cerebrospinal fluid (CSF) shunting. However, the accurate diagnosis and treatment of patients with NPH remains problematic, despite significant advances in brain imaging and ICP physiology.
Objectives - The primary aims of this study are:
- to confirm the ability of external lumbar drainage to increase the success rate of selectively shunting patients with NPH compared to historical controls
- to refine the diagnosis of NPH by determining whether the factors that change before and after lumbar drainage will predict failure to improve after shunting. A related aim is to assess the complications attributable to lumbar drainage.
- to perform a preliminary evaluation of programmable shunt valves for NPH compared to historical controls using fixed-pressure valves. A related aim is to determine whether post-op objective analysis of gait, cognitive function and urinary symptoms will help refine the programmable shunt setting on an individual basis.
Secondary study aims include:
Investigating the pathophysiology of NPH by: 1) correlating cortical vein compliance measured by MRI flow quantification studies with CSF pressure waveform analysis; 2)assessing funduscopic changes before and during ELD; 3) performing and cross correlating CSF chemical analysis on screening positive and negative patients as well as screening-positive patients who are shunt responsive versus unresponsive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Walking difficulties in both legs which has developed gradually, not explained by other conditions, either in combination with mental impairment and urinary incontinence
- •Brain CT or MRI findings of enlarged ventricles compared to established standards (minimum Evans ratio of 0.30 as measured by reviewing films)
- •Mental impairment must be mild to moderate, emerging with or after the walking difficulties
- •Age > or = 18 years old
- •MMSE (Mini-mental status exam): < or = 10
- •Urinary incontinence
排除标准
- •No or only minimal walking difficulties combined with severe dementia
- •Severe medical problems with limited life expectancy (less than six months)
- •Contraindications to surgery
- •Lack of informed consent
结局指标
主要结局
Evans Ratio
时间窗: initial and follow-up visits
A brain CT scan is obtained after the first week to ten days and the shunt is adjusted according to the patients signs and symptoms. Prior to any downward adjustment of the shunt valve (which allows more CSF drainage), a brain CT is obtained to look for subdural hematoma or effusion. If any type of subdural collection is found, the valve pressure is increased (to reduce CSF flow) until the collection resolves.
次要结局
- Physical Therapy, Occupational Therapy, and Speech Therapy(30 min per clinic visit)