Clinical trial NCT05647837: CSF Biomarkers in Idiopathic Intracranial Hypertension
Official title: Value of Cerebrospinal Fluid (CSF) Biomarkers in Patients of Idiopathic Intracranial Hypertension (IIH) as an Indicative of Visual Affection and Treatment Modalities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Hypertension
Keywords: biomarkers
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study is to high lighten the rule of CSF biomarkers in early diagnosis of IIH and in follow up to reach to a definite clinically based decision if this patient will improved on medical treatment or that patient is in need for surgical intervention.

Detailed description: Idiopathic intracranial hypertension (IIH) is a rare disease of increasing incidence recently\[1\], owing to the rising curve of obesity and weight gain\[2,3\]. It is a disease of elevated intracranial pressure without known obvious aetiology. The reported incidence of IIH is 1 to 3 cases per 100,000 people of the general population\[4\]. IIH is diagnosed by exclusion; as patients come with continuous headache repeated vomiting , pulsatile tinnitus and the hall landmark of this disease, visual disturbance. One of the most deleterious effect of IIH is through its effect on optic nerve (papilledema) leading to visual field defect, horizontal double vision and finally decrease of visual acuity. Despite this, these presentations may not appears collectively and patient can come with one or two of vague symptoms as in IIH without papilledema variant\[5\]. So IIH needs an accurate, trusted, and rapid tool for diagnosis and follow up. Modified Dandy criteria\[6,7\] gives an informative description for IIH and a differentiation from other causes of increase intracranial pressure through; Signs and symptoms of increased intracranial pressure, Absence of localizing findings on neurologic examination, Absence of deformity, displacement, or obstruction of the ventricular system except for evidence of increased cerebrospinal fluid pressure (greater than 200 mm water)\[8\]. Normal neuroimaging except for empty sella turcica, optic nerve sheath with filled out CSF spaces, and smooth-walled non flow-related venous sinus stenosis or collapse should lead to another diagnosis, No other cause of increased intracranial pressure present for CSF opening pressure of 200 to 250 mm water.

The clinical presentation of the disease is heterogeneous and often not correlating with the objective findings such as lumbar puncture opening pressure and papilledema. Currently, it is not possible to predict if a patient will respond to medical treatment, or which patients may develop severe permanent visual loss. Papilledema, the only non-invasive objective measurable treatment response, develops with substantial delay compared to intracranial pressure. Therefore, an objective tool indicating permanent optic nerve damage is sorely needed and will help guide treatment and predicting disease outcome. Biomarkers have this advantage as they allow early predicting optic nerve damage. For that reason CSF biomarkers deserve precise understanding for there rule in IIH which is the aim of our study.

Eligibility criteria: Inclusion Criteria:

- 1. All patients with signs and symptoms of increased intracranial pressure (headaches, nausea, vomiting, transient visual obscurations, papilledema).

2. CSF opening pressure \>25 cm water with normal CSF composition.

Exclusion Criteria:

* 1. localizing neurologic signs, except for unilateral or bilateral sixth cranial nerve palsy.

  2. Evidence of hydrocephalus, mass, infection, structural, or vascular lesion (including venous sinus thrombosis) on imaging.

  3. Patients with IIH who undergo surgical intervention (thecoperitoneal shunt or optic nerve fenestration) 4. Other identified causes of increased ICP.

Primary outcomes:
measure: Relation between lumper puncture opening pressure and specific biomarkers
timeFrame: Baseline
measure: Relation between lumper puncture opening pressure and visual disturbance
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: professor
name: Mahmoud H Ragab, professor
role: STUDY_CHAIR
affiliation: Assistant professor
name: Abdelhakeem A Essa, Ass. prof.
role: STUDY_DIRECTOR
References:
citation: Kalyvas A, Neromyliotis E, Koutsarnakis C, Komaitis S, Drosos E, Skandalakis GP, Pantazi M, Gobin YP, Stranjalis G, Patsalides A. A systematic review of surgical treatments of idiopathic intracranial hypertension (IIH). Neurosurg Rev. 2021 Apr;44(2):773-792. doi: 10.1007/s10143-020-01288-1. Epub 2020 Apr 25.
citation: Sinclair AJ, Ball AK, Burdon MA, Clarke CE, Stewart PM, Curnow SJ, Rauz S. Exploring the pathogenesis of IIH: an inflammatory perspective. J Neuroimmunol. 2008 Sep 15;201-202:212-20. doi: 10.1016/j.jneuroim.2008.06.029. Epub 2008 Aug 3.