Evaluating Raised Intracranial Pressure Using MR Elastography
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- MR elastography measurement of the brain elasticity
研究概览
简要总结
Investigators will compare magnetic resonance (MR) elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) imaging measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on magnetic resonance imaging (MRI).
详细描述
The goal of this study is to evaluate the brain elasticity in patients with idiopathic intracranial hypertension (IIH) and other forms of raised intracranial pressure, such as obstructive hydrocephalus. Investigators will evaluate for a correlation between brain stiffness and opening pressure on lumbar puncture. Investigators will also evaluate for changes in brain stiffness after interventions that are aimed at lowering intracranial pressure, including lumbar punctures, medications, and surgical interventions, such as ventriculoperitoneal shunts. Lastly, investigators will compare MR elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •All subjects will have the following inclusion criteria:
- •Group 1: Papilledema from idiopathic intracranial hypertension and other forms of elevated intracranial pressure, including obstructive hydrocephalus
- •Group 2: Patients without raised intracranial pressure.
- •All subjects will have the following
排除标准
- •Pregnancy (self-reported)
- •Individuals for whom MR is contraindicated
研究组 & 干预措施
Patients with increased intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
干预措施: MR elastography (Diagnostic Test)
Patients with increased intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
干预措施: MRI structural brain imaging (Diagnostic Test)
Patients with increased intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
干预措施: Lumbar puncture (Procedure)
Patients with increased intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
干预措施: Optical Coherence Tomography (OCT) imaging (Diagnostic Test)
Patients with increased intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, Optic nerve B-scan ultrasound and Lumbar puncture.
干预措施: Optic nerve B-scan ultrasound (Diagnostic Test)
Patient without raised intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, and Optic nerve B-scan ultrasound. Some patients will receive lumbar punctures.
干预措施: MR elastography (Diagnostic Test)
Patient without raised intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, and Optic nerve B-scan ultrasound. Some patients will receive lumbar punctures.
干预措施: MRI structural brain imaging (Diagnostic Test)
Patient without raised intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, and Optic nerve B-scan ultrasound. Some patients will receive lumbar punctures.
干预措施: Optical Coherence Tomography (OCT) imaging (Diagnostic Test)
Patient without raised intracranial hypertension
Patients will receive the MR elastography, MRI structural brain imaging, Optical Coherence Tomography (OCT) imaging, and Optic nerve B-scan ultrasound. Some patients will receive lumbar punctures.
干预措施: Optic nerve B-scan ultrasound (Diagnostic Test)
结局指标
主要结局
MR elastography measurement of the brain elasticity
时间窗: 1-2 weeks prior to lumbar puncture
The primary outcome measure is the difference in the brain elasticity on MR elastography between patients with raised intracranial pressure and those with normal intracranial pressure
次要结局
- MRI finding(1--2 weeks prior to lumbar puncture)
- Ocular Coherence Tomography (OCT) finding(1--2 weeks prior to lumbar puncture)
- Optic Nerve B-scan ultrasound finding(1--2 weeks prior to lumbar puncture)