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临床试验/NCT00600795
NCT00600795已完成不适用

Prognostic Value of Transforming Growth Factor-Beta 1 in Normal Pressure Hydrocephalus

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
1
主要终点
TGF beta-1 levels

研究概览

简要总结

Correlation of cerebrospinal fluid levels of transforming growth factor beta-1 with functional improvements after insertion of ventriculoperitoneal shunt for normal pressure hydrocephalus

详细描述

The goal of this research is to investigate a potential CSF biomarker of NPH as a new tool for both the diagnosis of NPH and prognosis of VPS placement. Transforming growth factor-b1 (TGF-b1) is a signaling molecule involved in three fundamental activities; suppression of cell proliferation, immunosuppression, and deposition of extracellular matrix through promotion of synthesis and inhibition of degradation.8 Previously, TGF-b1 had been implicated in the development of communicating hydrocephalus secondary to pre-term infant intraventricular hemorrhage9 and adult aneurysmal sub-arachnoid hemorrhage.10, 11 Recently, an investigation demonstrated elevated levels of TGF-b1 in patients with shunt-responsive NPH compared to non-NPH patients.12

The specific aims of this research proposal are to:

  1. Correlate CSF levels of TGF-b1 with the clinical response of patients diagnosed with NPH to VPS placement.
  2. Correlate CSF levels of TGF-b1 with optimal VPS pressure settings.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Diagnosis of Normal Pressure Hydrocephalus

排除标准

  • Patients not diagnosed with Normal Pressure Hydrocephalus

结局指标

主要结局

TGF beta-1 levels

时间窗: Time of Surgery

Mini-mental status exam

时间窗: Pre-operative, 3 and 12 months post-operatively

Modified barthel index

时间窗: Pre-operative, 3 and 12 months post-operatively

Tinetti mobility assessment

时间窗: Pre-operative, 3 and 12 months post-operatively

次要结局

  • Programmable shunt setting(Pre-operative, 3 and 12 months post-operatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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