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临床试验/NCT06353412
NCT06353412尚未招募不适用

Evaluation of the Current Treatment Methods of Idiopathic Intracranial Hypertension

Assiut University0 个研究点目标入组 64 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
主要终点
Complication

研究概览

简要总结

Aim of the study :

  1. to determine the response to each treatment plan.
  2. to determine when to choose specific treatment method.
  3. to determine complication of each type of treatment method

详细描述

Idiopathic intracranial hypertension (IIH) is caused by an elevation of intracranial pressure (ICP). The condition mainly affects obese young women of childbearing age.

In a recent study in the United Kingdom University of Kentucky urokinase, the estimated annual incidence was 4.7 % which represents a growth of 108% in 14 years, and parallels the growth of obesity prevalence .

The combination of raised intracranial pressure, without hydrocephalus or mass lesion, normal cerebrospinal fluid (CSF) composition and where no underlying aetiology is found are accepted criteria for the diagnosis of IIH.

The two most prominent symptoms of IIH are progressive visual deterioration and chronic headache, although additional symptoms including cranial nerve palsies, cognitive deficits, tinnitus and olfactory dysfunction are frequently also part of the clinical presentation. While the visual dysfunction is known to largely result from a pressure-induced papilledema, the origin of the IIH-related headache is less clear and therapeutic approaches are less investigated.

The conventional treatment for IIH involves weight loss, steroids, diuretics, and serial lumbar punctures and surgical treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patient has symptoms of increased intracranial pressure with :-
  • papilledema,
  • normal neurological examination,(except 6th nerve palsy),
  • elevated opening pressure( >=25 cm) csf,
  • normal csf content

排除标准

  • Any patient diagnosed with increased intracranial pressure due to:
  • sinus thrombosis or stenosis will be excluded from this study and .accordingly endovascular stenting as a method of treatment will be excluded from this study.

结局指标

主要结局

Complication

时间窗: 1 year

Complication of each treatment option

Patient improvement regarding headache, visual symptoms

时间窗: 1 year

Determine the Severity of headache on scale from (0-10) ((0-4)\>mild, (5-7)\>moderate, (8-10)\>sever)

Patients improvement regarding fundus examination during regular visual assessment

时间窗: 1 year

Fundus examination grading (1-2-3-4)

次要结局

  • Other(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Ahmed Mohamed Mansour

Doctor

Assiut University

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