Current Treatment Methods of Idiopathic Intracranial Hypertension

IIH - Idiopathic Intracranial Hypertension Clinical Trial

Official title:

Evaluation of the Current Treatment Methods of Idiopathic Intracranial Hypertension

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06353412
• Other study ID #: treatment methods of IIH
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: March 9, 2026

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: Mohamed AM Mansour, Master
• Phone: 01060685379
• Email: Mohamed.15235787[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: March 9, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• IIH - Idiopathic Intracranial Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

Procedure:
• Lumbar puncture
Medical treatment Lumbar puncture Theco peritoneal shunt

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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