Phenotypes, Biomarkers and Pathophysiology in INPH
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- DTIALPS
研究概览
简要总结
The aim of this study is to determine the clinical spectrum and natural progression of idiopathic normal pressure hydrocephalus （iNPH ) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.
详细描述
Due to the heterogeneity of the etiology of idiopathic normal pressure hydrocephalus , almost all published studies on the clinical outcome and prognostic factors of iNPH are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of iNPH and determine the main prognostic factors through clinical scales, biomarkers and imaging.
At study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy.
Optionally, additional examinations may be performed including imaging，such as DTIALPS, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who was diagnosed as idiopathic normal pressure hydrocephalus
排除标准
- •patient received surgical treatment or interventional treatment before patient is pregnant patient unable to complete follow-up patient with other types of hydrocephalus other nervous system diseases
结局指标
主要结局
DTIALPS
时间窗: Change from Baseline at 6 months after VP shunt
Change of DTIALPS singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed.
次要结局
- modified Rankin scale(Change from Baseline at 6 months after VP shunt)
- Kiefer score(Change from Baseline at 6 months after VP shunt)
- Mini mental state Examination(Change from Baseline at 6 months after VP shunt)
- Change in the resting state fMRI(Change from Baseline at 6 months after VP shunt)
- omic pattern of CSF in iNPH patients(Change from Baseline at 6 months after VP shunt)
- Gait evaluation(Change from Baseline at 6 months after VP shunt)