Investigating biomarkers in idiopathic intracranial hypertension
Biomarkers in the Etiology of Idiopathic Intracranial Hypertension
This study is testing if certain blood markers can help us understand and treat newly diagnosed idiopathic intracranial hypertension, which causes high pressure in the brain and can lead to headaches and vision problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06059703 on ClinicalTrials.gov |
What this trial studies
This study focuses on idiopathic intracranial hypertension (IIH), a condition marked by increased intracranial pressure and associated complications like severe headaches and risk of vision loss. It aims to explore the underlying mechanisms of IIH, particularly the role of cerebral venous drainage obstruction and transverse sinus stenosis. The methodology includes blood sampling and intracranial pressure measurements to identify potential biomarkers and assess treatment efficacy. The study targets patients with newly diagnosed untreated IIH who meet specific diagnostic criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed untreated IIH and specific diagnostic criteria.
Not a fit: Patients with chronic IIH, significant comorbidities, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients suffering from idiopathic intracranial hypertension.
How similar studies have performed: While the study explores a complex condition, similar approaches in understanding IIH have shown promise, but this specific investigation into biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Montpellier
- University Hospital of Montpellier - Gui de Chauliac — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Federico CAGNAZZO, MD
- Email: f-cagnazzo@chu-montpellier.fr
- Phone: 00334 67 33 75 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.