Idiopathic intracranial hypertension with venous sinus stenosis
Conditions
Interventions
Standard medical treatment:Use of acetazolamide, weight loss with a low calorie diet, and taking analgesics for headache
Stent treatment group:Stent treatment
Sponsors
Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged from 18 to 60 years old were diagnosed with idiopathic intracranial hypertension according to Friedman Jacobson modified dandy criteria, and the onset was more than 2 months, with at least one side of fundus edema; 2.Lumbar puncture opening pressure >= 250 mmH2O within 6 weeks before enrollment (1)Neuroimaging showing normal brain parenchyma without hydrocephalus, mass, or any structural lesion and no evidence of meningeal enhancement on CT or MRI; (2)Normal cerebrospinal fluid (CSF) composition; 3.Localized venous sinus stenosis (VSS) with stenotic degree >= 50% on DSA, and pressure gradient across stenosis >= 8 mmHg; 4.At least one eye had the presence of papilledema; 5.Patients or their relatives signed written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous surgery for IIH, including optic nerve sheath fenestration (ONSF), CSF shunting, decompressive craniectomy or venous sinus stenting; 2. Visual loss due to other etiologies (eg, retinal drusen, retinal and optic neuropathy, cataracts, etc); 3. Other condition requiring the use of diuretics, steroids or other drugs to reduce intracranial pressure; 4. DSA showed diffused venous sinus stenosis, cortical or deep vein stenosis; 5. A history of severe thyroid disease and iodine allergy; 6. Pregnant or lactating women; 7. Severe cardiopulmonary, liver or kidney failure; 8. Known hereditary or acquired haemorrhagic diathesis; 9. Known hereditary or acquired thrombophilia; 10. Platelet counts or coagulation abnormality; 11. Major surgery or severe trauma or any traumatic brain injury within the previous 14 days; 12. A history of cerebral hemorrhage, arteriovenous malformation, intracranial aneurysm or tumor; 13. Other life threatening illness (eg, advanced cancer) likely to lead to death within a few months; the physical, psychological and social status of patients may affect follow-up (eg, drug addiction, advanced malignant disease, no telephone, no family, etc); cannot tolerate general anesthesia; 14. Increased intracranial pressure due to other secondary factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in intracranial pressure measured by lumbar puncture opening pressure from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in perimetric mean deviation (PMD) from baseline in the eye with the most severe visual loss;Papilledema Grade: Frisén grade (0-5 scores, and higher scores mean worse outcome);The change in thickness of retinal nerve fiber layer and total retina measured by optical coherence tomography (OCT) from baseline;The change in vision measured by National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) and 10-item neuro-ophthalmic supplement to the NEI-VFQ-25 from baseline;The change in headache measured by Headache Impact Test-6 (HIT-6) questionnaire from baseline;The change in pulsatile tinnitus from baseline to 6 months#pulsatile tinnitus was assessed using the Tinnitus Handicap Inventory (THI), which is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living;The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) from baseline; | — |
Countries
China
Contacts
Public ContactDapeng Mo
Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed