Current Treatment Methods of Idiopathic Intracranial Hypertension

Not yet recruiting

• Conditions: IIH - Idiopathic Intracranial Hypertension

• Registration Number: NCT06353412
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Surgical intervention should be conducted as soon as medical treatment fails. It is not acceptable to delay the intervention for patient with sever visual deterioration . Therefore surgery is indicated once visual loss continues despite optimum medical therapy .

Medical treatment with acetazolamide and serial lumbar punctures represent the initial management, in such cases preserving surgery to non-responding cases and those who cannot tolerate medical treatment.

Surgical treatment include lumboperitoneal shunt insertion , navigation guided ventriculo-peritoneal shunt ,endovascular stenting of sinuses in cases of sinus thrombosis and stenosis .

Study Timeline

• Study First Submitted: 2024-03-20
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-02
• Last Update Submitted: 2024-04-02
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Study Start: 2024-06-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-03-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complication	1 year	Complication of each treatment option
Patient improvement regarding headache, visual symptoms	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	1 year	Fundus examination grading (1-2-3-4)

Secondary Outcome Measures

Name	Time	Method
Other	1 year	Cost of treatment and hospital stay (Relation between type of treatment and cost Of treatment, time of hospital stay) (type of treatment and number of days of hospital stay)