Magnetic Resonance Elastography in Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Mean shear modulus
研究概览
简要总结
The purpose of this project is to assess the utility of a new magnetic resonance technique called magnetic resonance elastography (MRE) in the non-invasive diagnosis of normal pressure hydrocephalus. The investigators hypothesize that MRE produces a unique imaging signature for hydrocephalus that distinguishes the disease from the normal (non-hydrocephalic) but atrophied brain, a distinction not possible with conventional MR imaging studies that are presently available.
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
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >21;
- •One or more of the following complaints: memory loss/dementia, urinary incontinence, or progressive gait disturbance
- •Ventriculomegaly defined as temporal horn width >2 mm or a FH:ID ratio>30% on computed tomography or MRI, where FH is the maximal distance between the frontal horns and ID is the internal diameter from inner table to inner table of the skull at this level (Greenberg)
- •A diagnosis of any adult onset hydrocephalus (NPH, post-traumatic, post-hemorrhagic, obstructive, or idiopathic) will be considered for enrollment in this study
排除标准
- •Implanted neuro-stimulator or cardiac pacemaker
- •Known coagulopathy; major organ dysfunction
- •End-stage congestive heart failure
- •Oxygen-dependent pulmonary disease, hepatic cirrhosis, or dialysis- dependent renal failure; or other condition which, according to the assessment of the treating surgeon or anesthesia team
- •Precludes consideration of elective surgery
- •Patients who may be pregnant will be excluded from this study as well
研究组 & 干预措施
MRE
干预措施: MRE (Device)
结局指标
主要结局
Mean shear modulus
时间窗: 15 Years
The primary outcome measure will be mean shear modulus determined from pre-operative (and pre-drain placement) MRE in patients who demonstrate clinical improvement with trial CSF drainage versus patients who do not demonstrate improvement.
次要结局
- Pre-operative (and pre-drain placement) shear modulus in the experimental group will be compared with various assessments of clinical improvement after VP shunting.(15 Years)
研究者
Keith D. Paulsen
Professor
Dartmouth-Hitchcock Medical Center