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.
The DIVE-IIN-EARLY trial is a multicenter randomized controlled trial designed to evaluate whether transverse venous sinus stenting is more effective than best medical therapy alone as first-line treatment for patients with idiopathic intracranial hypertension (IIH). The study targets patients with a new diagnosis of IIH with bilateral transverse sinus stenosis or unilateral stenosis of the dominant transverse sinus with a hypoplastic contralateral sinus. Idiopathic intracranial hypertension is, in most cases, associated with narrowing of the transverse sinus vein, which may be the cause of increased intracranial blood pressure, resulting in the accumulation and increase in intracranial fluid pressure. This increased pressure is thought to be responsible for papilledema, chronic headaches, and tinnitus, among other symptoms. Restoring a normal luminal diameter of the transverse sinus using a stent could therefore allow for the rapid restoration of normal intracranial pressures and an improvement in various symptoms. Stent implantation in the transverse sinus is now part of standard care, but no large-scale clinical trial has formally established the superiority of the technique compared to the standard of care (drug therapy combined with weight gain). This study aims to provide evidence on the potential benefits of transverse venous sinus stenting as a treatment option for patients with idiopathic intracranial hypertension, which could significantly change the current management approach to this disease. Usual medication for this condition is acetazolamide, but it's efficacy as well as it's tolerance is mostly poor. By proposing stenting in the early phase of the disease, one could avoid long term symptoms such as loss of vision and chronic headache.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Acetazolamide will be introduced at the time of papilledema discovery. Weight loss will be recommended.
Transverse venous sinus will be stented by neuro-radiological intervention
CHU de Montpellier Hôpital Gui de Chauliac
Montpellier, France
RECRUITINGCHU de REIMS
Reims, France
NOT_YET_RECRUITINGCHU de Toulouse
Toulouse, France
NOT_YET_RECRUITINGRate 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.
Time frame: 3 months
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)
Time frame: 3 and 12 months
Monthly headache days
Change in monthly headache days (within the last month) reported on patients' dairy
Time frame: 3 and 12 months
THI score
Change in THI (Tinnitus Handicap Inventory) score
Time frame: 3 and 12 months
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.
Time frame: 3 and 12 months
Visual acuity
Change of visual acuity score evaluated on ETDRS (far vision) at 4 meters and reproducible lighting, and Parinaud scale (near vision) using the best optical correction
Time frame: 3 and 12 months
Papilledema
Change of papilledema assessed on Frisen score and RNFL on OCT
Time frame: 3 and 12 months
Patient's autonomy
Change in quality of life assessed on EQ5D questionnaire
Time frame: 3 and 12 months
Patient's cognition
Change in Montreal Cognitive Assessment (MoCA)
Time frame: 12 months
Cognition
Change in Trail Making Test (TMT) A and B
Time frame: 12 months
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