Non-invasive Estimation of CSF Pressure Using MRI in Patients With Spontaneous Intracranial Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Intracranial Pressure Measurements Estimated by the MRICP Technique.
研究概览
简要总结
The purpose of this study is to estimate the intracranial pressure (ICP, the pressure in your head) in subjects with intracranial hypotension (a condition caused by leakage of the fluid that surrounds your brain and spine) using non-invasive magnetic resonance imaging (MRI) techniques, and to determine whether changes in estimated ICP are seen after treatment of this condition.
详细描述
Subjects with known intracranial hypotension who are scheduled to undergo standard-of-care CSF pressure measurement using lumbar puncture prior to planned epidural patch treatment will first undergo a research MRI of the brain in order to estimate ICP. The imaging protocol is listed in Appendix 1. All research scans are performed without intravenous contrast. Approximate scan time per session will be 20-22 minutes.
Subjects will then undergo lumbar puncture according to the standard-of-care treatment plan. Estimated values of CSF pressure derived from MRI will be compared to values measured during lumbar puncture. Patients will then undergo standard-of-care epidural patching. A repeat research MRI after epidural patching will be performed to assess for differences in pre- and post-treatment scans.
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
- •Known diagnosis of intracranial hypotension, established by the following criteria: the presence of orthostatic headache, and one or more of the following criteria: prior CSF opening pressure ≤6 cmH20, demonstration of an active spinal CSF leak on prior spine imaging, or cranial MRI changes of intracranial hypotension.15
- •Ability to provide informed consent.
- •Expected ability to complete standard-of-care procedures (lumbar puncture and epidural patching)
排除标准
- •Known contraindication to MRI (pacemaker, MRI incompatible hardware, etc.)
- •Severe claustrophobia or other condition requiring the need for anxiolysis, sedation, or any other medication for MRI scanning
- •Inability or expected inability to complete study interventions as scheduled
- •Any known contraindication to standard-of-care procedures (e.g. coagulopathy, allergic reaction to required medication, lack of vascular access, etc.)
结局指标
主要结局
Intracranial Pressure Measurements Estimated by the MRICP Technique.
时间窗: During scan, approximately 30 minutes
The measurement of the momentary differences between the volumes of blood and CSF entering and leaving the cranium during the cardiac cycle provides an estimate of the intracranial volume change, and the pressure difference is estimated using the derivative of the CSF velocities.
Cerebro Spinal Fluid Pressure Measured by Lumbar Puncture
时间窗: During lumbar procedure, up to 2 hours
The CSF pressure measured at lumbar puncture (LP), is 100-180 mm of H2O (8-15 mm Hg) with the patient lying on the side and 200-300 mm with the patient sitting up.
次要结局
- Change in Caliber to the Transverse Venous Sinus Caliber(Baseline, 24 hours)
- Change in Intracranial Pressure Estimated With MR Technique(Baseline, 24 hours)
- Change in Flow Velocity Through the Transverse Dural Venous Sinus(Baseline, 24 hours)