Clinical trial NCT06353412: Current Treatment Methods of Idiopathic Intracranial Hypertension
Official title: Evaluation of the Current Treatment Methods of Idiopathic Intracranial Hypertension
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: IIH - Idiopathic Intracranial Hypertension
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients have symptoms of increased intracranial hypertension presenting to Assiut University hospital

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 .

Eligibility criteria: 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.

Primary outcomes:
measure: Patient improvement regarding headache, visual symptoms
timeFrame: 1 year
measure: Patients improvement regarding fundus examination during regular visual assessment
timeFrame: 1 year
measure: Complication
timeFrame: 1 year
Secondary outcomes:
measure: Other
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Radwan Elnouby, Professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Wael M Ali, AssProfessor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed A Ragaee, AssProfessor
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
citation: 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.