Assessment of Raised Intracranial Pressure in Patients With Idiopathic Intracranial Hypertension by Optic Nerve Sheath Diameter and Transcranial Doppler Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Correlation between opening pressure and ONSD
研究概览
简要总结
Idiopathic Intracranial Hypertension (IIH) is a rare disease, primarily affecting overweight females of child-bearing age. Patients suffer from increased intracranial pressure (ICP), typically resulting in headaches, visual disturbances and bilateral papilledema, pulsatile tinnitus and cognitive deficits. The disease is difficult to diagnose, treat and monitor. The only current method of measuring the ICP in day-to-day clinical practice is by lumbar puncture. This procedure is invasive, and often painful for the patient. There is an unmet need of methods that can reliable measure or estimate ICP in a non-invasive manner. Ultrasound is one such potential method, and the aim of this study is to investigate the use of ocular ultrasound and transcranial doppler to measure or estimate ICP.
详细描述
This study is a prospective cohort study. Investigators plan to include 50 patients in whom the IIH-diagnosis is suspected. Patients are referred from general practitioners, neurologists or ophthalmologists to the Danish Headache Center or admitted to the Neurology ward when the IIH diagnosis is suspected.
As part of an established routine clinical work-up to establish the diagnosis of IIH, all patients will undergo (according to the Friedman criteria) the following examinations:
A)
- An interview (history taking) and clinical examination
- Routine laboratory tests (blood tests)
- Ophthalmological examination
- Lumbar puncture with measurement of the ICP
- Magnetic resonance imaging (MRI) of the brain
Additionally the following investigations will be performed at baseline (before and after lumbar puncture):
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65
- •Patients in whom the IIH diagnosis is suspected/or confirmed
- •The diagnosis of migraine with or without aura or tension-type headache is allowed as a comorbid headache type.
- •Participants must read and understand the Danish language, or have an official interpreter present to be able to understand the work-up and sign the participation consent for the study
排除标准
- •Pregnant or breastfeeding females
- •Patients who do not need a diagnostic lumbar puncture at the time of evaluation
- •Patients treated with acetazolamide, topiramate or furosemide for IIH or suspected IIH before inclusion in the study (baseline)
- •Any other primary or secondary headache diagnosis than migraine with or without aura or tension type headache as a comorbid disorder
- •Patients in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases
- •Participants with secondary causes of raised intracranial pressure, or patients that have been treated for such (e.g. brain tumor, hydrocephalus, stroke or severe head injury)
- •Participants with known atherosclerotic disease or known heart disease
- •CONTROL GROUP (ARM 2):
- •Inclusion criteria:
- •Age 18-65
- •Healthy persons who do not suffer from any form of primary headache except infrequent tension-type headache
- •Participants must read and understand the Danish language or have an official interpreter present to be able to sign the participation consent for the study.
- •Exclusion criteria:
- •Pregnant or breastfeeding females
- •Participants in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases
结局指标
主要结局
Correlation between opening pressure and ONSD
时间窗: 1 year
Optic nerve sheath diameter (ONSD) potential correlation with opening pressure.
Correlaton between opening pressure and ONSD/ETD ratio
时间窗: 1 year
ONSD/ETD (external transverse diameter) ratio and potential correlation with opening pressure.
Comparison of ONSD in IIH and healthy controls
时间窗: 1 year
Comparison of ONSD in patients with elevated ICP (IIH) and healthy controls, age- sex and BMI matched.
次要结局
- Optic disc elevation(1 year)
- Neuro-ophthalmological evaluation of papilledema versus ultrasound evaluation of the optic nerve(2 years)
- ONSD diameter on MR c in patients with IIH(1 year)
- Changes in the optic nerve (ONSD)(6 months)
- Changes in the optic nerve (ODE)(6 months)
- TCD (PI - pulsatility index) in patients with IIH(2 years)
- TCD (RI - resistance index) in patients with IIH(2 years)
- TCD (MBFV - mean blood flow velocity) in patients with IIH(2 years)
研究者
Johanne Severinsen
Medical Doctor
Danish Headache Center