RecruitingNot ApplicableNCT06059703

Biomarkers in the Etiology of Idiopathic Intracranial Hypertension


Sponsor

University Hospital, Montpellier

Enrollment

60 participants

Start Date

Nov 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Idiopathic intracranial hypertension (IIH) is a condition characterized by an increase in intracranial pressure (ICP), papilledema with a risk of permanent visual loss, and severe headaches that profoundly affect quality of life. To date the exact pathophysiology of IIH remains unknown. IIH is considered a complex neurometabolic and neuroendocrine disorder, favored by female gender, and obesity. In the majority of patients (80% of the cases) IIH is associated with obstruction of cerebral venous drainage with stenosis of the transverse sinus. This stenosis may be the main underlying cause in the so-called "venogenic" form of IIH. Equally, in the absence of a stenosis, obstruction may occur when otherwise normal venous sinuses are compressed by the increased ICP, the so-called "non-venogenic" form of IIH. An innovative treatment of IIH with associated venous stenosis includes stenting of the transverse sinus stenosis. This strategy may allow resolution of papilledema and ICP reduction rates up to 80%. Although the pathogenesis of IIH is still poorly understood, inflammatory mechanisms, autoimmune reactions, and hormonal abnormalities of notably androgens, have been proposed to contribute to its pathophysiology. The function of the blood-brain barrier (BBB) has been studied by determining the prevalence of extravasation of endogenous proteins such as fibrinogen. A growing body of the literature shows a correlation between increased ICP and metabolic/hormonal changes. The improvement of IIH treated with acetazolamide and/or stenting appears to correlate with the reduction of ICP. Yet the association of this reduction with metabolic changes at the peripheral and central blood level as well as the CSF remains unclear. The search for specific inflammatory, immunological and hormonal biomarkers in patients with IIH and their variation in relation to the ICP should provide a better understanding of its etiology.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for biological markers (biomarkers) that help explain why some people develop idiopathic intracranial hypertension (IIH) — a condition where pressure in the fluid around the brain gets too high for no clear reason, causing severe headaches and vision problems. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with IIH that has not yet been treated - Your diagnosis meets standard criteria, including abnormally high cerebrospinal fluid pressure confirmed by lumbar puncture - You have narrowing of the veins that drain your brain on both sides (bilateral transverse sinus stenosis) **You may NOT be eligible if...** - You have an allergy to contrast dye (nickel or titanium) - You have allergies or contraindications to the study medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBlood punction

Peripheral blood sampling (5 ml) at inclusion and 3 months after treatment

PROCEDURECentral blood sampling

Central blood sampling (2 ml) at inclusion and 3 months after treatment

PROCEDUREIntracranial pressure measurement

Intracranial pressure measurement at sinus level with micro-catheter at inclusion and 3 months after treatment


Locations(1)

University Hospital of Montpellier - Gui de Chauliac

Montpellier, France

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NCT06059703


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