Current Treatment Methods of Idiopathic Intracranial Hypertension

April 2, 2024 updated by: Mohamed Ahmed Mohamed Mansour, Assiut University

Evaluation of the Current Treatment Methods of Idiopathic Intracranial Hypertension

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients have symptoms of increased intracranial hypertension presenting to Assiut University hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient improvement regarding headache, visual symptoms
Time Frame: 1 year
Determine the Severity of headache on scale from (0-10) ((0-4)>mild, (5-7)>moderate, (8-10)>sever)
1 year
Patients improvement regarding fundus examination during regular visual assessment
Time Frame: 1 year
Fundus examination grading (1-2-3-4)
1 year
Complication
Time Frame: 1 year
Complication of each treatment option
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other
Time Frame: 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)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Radwan Elnouby, Professor, Assiut University
  • Study Director: Wael M Ali, AssProfessor, Assiut University
  • Study Director: Mohamed A Ragaee, AssProfessor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

March 9, 2026

Study Registration Dates

First Submitted

March 20, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • treatment methods of IIH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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