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Not yet recruitingNCT06353412Updated Apr 9, 2024

Current Treatment Methods of Idiopathic Intracranial Hypertension

An observational study in IIH - Idiopathic Intracranial Hypertension, sponsored by Assiut University. Not yet recruiting. Open to participants aged 16 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-09.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
16 Years to 75 Years
Sex
All
01

Study 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
Read the 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 .

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Conditions studied

  • IIH - Idiopathic Intracranial Hypertension
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In context

Intracranial Hypertension

185 studies on the registry are indexed under Intracranial Hypertension; 45 are open to participants now.

This study's planned enrollment of 64 is close to the median of 60 across 80 observational studies indexed under Intracranial Hypertension.

Browse Intracranial Hypertension studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (estimated)
Patient registry
No

Interventions

  • ProcedureLumbar puncture

    Medical treatment Lumbar puncture Theco peritoneal shunt

    Also known as: Theco peritoneal shunt

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: 1 year

  2. Patients improvement regarding fundus examination during regular visual assessment

    Fundus examination grading (1-2-3-4)

    Time frame: 1 year

  3. Complication

    Complication of each treatment option

    Time frame: 1 year

Secondary outcomes

  1. 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)

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Bubshait RF, Almomen AA. The Endonasal Endoscopic Management of Cerebrospinal Fluid Rhinorrhea. Cureus. 2021 Feb 20;13(2):e13457. doi: 10.7759/cureus.13457. PubMed 33777546 ↗
  • 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. PubMed 30356129 ↗
  • 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. PubMed 23966248 ↗
  • 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. PubMed 26700907 ↗
  • 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. PubMed 29368949 ↗
  • 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. PubMed 35465882 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06353412
Lead sponsor
Assiut University
Responsible party
Mohamed Ahmed Mohamed Mansour (Doctor, Assiut University) — Principal investigator
First posted
Apr 9, 2024
Start date
Jun 1, 2024 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Mar 9, 2026 (estimated)
Last update
Apr 9, 2024

Study contacts

Mohamed AM Mansour, Master
Contact
Mohamed.15235787@med.aun.edu.eg
01060685379
Radwan Elnouby, Professor
study chair · Assiut University
Wael M Ali, AssProfessor
study director · Assiut University
Mohamed A Ragaee, AssProfessor
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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