This study is aimed at patients suffering from recently discovered intracranial hypertension, caracterized by visual loss, chronic headache and/or tinnitus. The goal is to evaluate if stenting of a specific vein in the brain could decrease the hypertension and improve associated symptoms. Patients will be randomly assigned in either best medical care group (recommended medication associated with weight loss) or interventional group (best medical car + stenting of the specific vein) and will undergo specific follow-up visits after 1, 3 and 12 months.
Subject is ≥ 18 years old at inclusion.
Subject with definite new diagnosis (˂ 3 months) of IIH satisfying the modified Dandy criteria (A to E)
Subject with intracranial TVS stenosis on dominant transverse sinus and hypoplastic contralateral one (or bilateral TVS stenosis) diagnosed on MRI
Normal MRI findings excepted intracranial TVS stenosis or IIH related abnormalities
Subject previously treated with acetazolamide for IIH
Known contrast product, Nickel, titanium allergy
Exposure to an oral drug, substance, or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis (lithium, vitamin A, tetracycline and related compounds)
History of intracranial venous thrombosis or intracranial neoplasia
Parallel
Best medical care
DrugAcetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended.
Intervention (stenting)
DeviceTransverse venous sinus will be stented by neuro-radiological intervention
Rate of patients with resolved papilledema and normalization of intra-cranial pressure
Rate of patients with resolved papilledema (defined as Frisén scale grade 0-1 on OCT, without ganglion cells damage, and RNFL ˂ 130 µm) and normalization of intra-cranial pressure (defined as ≤ 25 cm H20 or 18 mmHg measured on lumbar puncture) at 3 months. Papilledema will be studied in the most affected eye.
HIT-6 grading scale score
Change in mean HIT-6 grading scale score (patient's questionnaire containing 6 questions to evaluate the severity of headache)
Monthly headache days
Change in monthly headache days (within the last month) reported on patients' dairy
THI score
Change in THI (Tinnitus Handicap Inventory) score
Visual field
Change in decibel of Mean Deficit visual field assessed on automated perimetry in both eyes with Humphrey Field Analyzer SITA Standard 24-2 test pattern. Each participant will have at least 2 initial visual field examinations conducted at least 30 minutes apart. The 2 Perimetric Mean Deviation (PMD) measurements will be averaged.
Click on the lead sponsor to view all of their trials.
University Hospital, Montpellier
Lead sponsor
Ministère de la Santé
Collaborator
