Current Treatment Methods of Idiopathic Intracranial Hypertension

NCT ID: NCT06353412

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-03-09

Brief Summary

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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

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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 .

Conditions

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IIH - Idiopathic Intracranial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Lumbar puncture

Medical treatment Lumbar puncture Theco peritoneal shunt

Intervention Type PROCEDURE

Other Intervention Names

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Theco peritoneal shunt

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ahmed Mohamed Mansour

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Radwan Elnouby, Professor

Role: STUDY_CHAIR

Assiut University

Wael M Ali, AssProfessor

Role: STUDY_DIRECTOR

Assiut University

Mohamed A Ragaee, AssProfessor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Mohamed AM Mansour, Master

Role: CONTACT

01060685379

References

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Bubshait RF, Almomen AA. The Endonasal Endoscopic Management of Cerebrospinal Fluid Rhinorrhea. Cureus. 2021 Feb 20;13(2):e13457. doi: 10.7759/cureus.13457.

Reference Type BACKGROUND
PMID: 33777546 (View on PubMed)

Mollan SP, Aguiar M, Evison F, Frew E, Sinclair AJ. The expanding burden of idiopathic intracranial hypertension. Eye (Lond). 2019 Mar;33(3):478-485. doi: 10.1038/s41433-018-0238-5. Epub 2018 Oct 24.

Reference Type BACKGROUND
PMID: 30356129 (View on PubMed)

Friedman DI, Liu GT, Digre KB. Revised diagnostic criteria for the pseudotumor cerebri syndrome in adults and children. Neurology. 2013 Sep 24;81(13):1159-65. doi: 10.1212/WNL.0b013e3182a55f17. Epub 2013 Aug 21.

Reference Type BACKGROUND
PMID: 23966248 (View on PubMed)

Markey KA, Mollan SP, Jensen RH, Sinclair AJ. Understanding idiopathic intracranial hypertension: mechanisms, management, and future directions. Lancet Neurol. 2016 Jan;15(1):78-91. doi: 10.1016/S1474-4422(15)00298-7. Epub 2015 Dec 8.

Reference Type BACKGROUND
PMID: 26700907 (View on PubMed)

Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

Reference Type BACKGROUND
PMID: 29368949 (View on PubMed)

Akhter A, Schulz L, Inger HE, McGregor JM. Current Indications for Management Options in Pseudotumor Cerebri. Neurol Clin. 2022 May;40(2):391-404. doi: 10.1016/j.ncl.2021.11.011. Epub 2022 Mar 31.

Reference Type BACKGROUND
PMID: 35465882 (View on PubMed)

Other Identifiers

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treatment methods of IIH

Identifier Type: -

Identifier Source: org_study_id

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