Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06059703

Biomarkers in the Etiology of Idiopathic Intracranial Hypertension

Led by University Hospital, Montpellier · Updated on 2024-05-28

60

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Biomarkers in the Etiology of Idiopathic Intracranial Hypertension

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years and older
  • Newly diagnosed untreated idiopathic intracranial hypertension following the modified Dandy criteria
  • Normal cerebrospinal fluid composition
  • Elevated cerebrospinal fluid pressure greater than 25 cm H2O on lumbar puncture
  • Significant pressure gradient of 8 mmHg or more at the stenosis site
  • Presence of bilateral transverse sinus stenosis or unilateral stenosis with hypoplastic contralateral sinus
Not Eligible

You will not qualify if you...

  • Allergy to contrast media such as nickel or titanium
  • Allergy or contraindication to antiplatelet agents
  • Current use of anti-inflammatory treatment
  • Presence of chronic inflammatory disease
  • History of intracranial venous thrombosis, cerebral hemorrhage, or thrombophilia
  • History of intracranial tumor
  • Fulminant IIH with acute visual loss
  • Optic nerve atrophy with papilledema (chronic IIH)
  • Female who is pregnant, breastfeeding, or planning pregnancy within 3 months
  • Major comorbidities posing high procedural risk
  • Life expectancy less than 6 months
  • Adult under guardianship, conservatorship, or incapacitated
  • Refusal to consent after receiving full information
  • Not covered by or beneficiary of the French social security system

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital of Montpellier - Gui de Chauliac

Montpellier, France, 34090

Actively Recruiting

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Research Team

F

Federico CAGNAZZO, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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