Status:
RECRUITING
Biomarkers in the Etiology of Idiopathic Intracranial Hypertension
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Idiopathic Intracranial Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 profo...
Detailed Description
Idiopathic intracranial hypertension (IIH) is a condition characterized by increased intracranial pressure (ICP) of unknown cause, papilledema with the risk of permanent visual impairment, and severe ...
Eligibility Criteria
Inclusion
- 18 years and older
- Patients with newly diagnosed untreated HII (following the modified Dandy criteria) with normal CSF composition, abnormal CSF pressure at the lumbar puncture (\>25 cm H2O), and significant pressure gradient at the level of the stenosis (≥8 mmHg)
- Presence of bilateral transverse sinus stenosis (or unilateral with hypoplastic contralateral sinus).
Exclusion
- Allergy to contrast media (nickel, titanium)
- Allergy or contraindication to antiplatelet agents
- Patient on anti-inflammatory treatment
- Chronic inflammatory disease
- History of intracranial venous thrombosis, cerebral hemorrhage, thrombophilia
- History of intracranial tumor
- Fulminant IIH with acute visual loss
- Optic nerve atrophy with papilledema (chronic IIH)
- Female being pregnant, breastfeeding, or planning to become pregnant in the next 3 months
- Major comorbidities with high procedural risk
- Life expectancy \< 6 months
- Adult under guardianship or conservatorship or incapacitated
- Refusal of consent after receiving all necessary information
- Not covered by or not a beneficiary of the French social security system
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 27 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06059703
Start Date
November 27 2023
End Date
March 27 2026
Last Update
May 28 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital of Montpellier - Gui de Chauliac
Montpellier, France, 34090