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This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.
Idiopathic intracranial hypertension (IIH) has long been associated with the hallmark clinical triad of headaches, papilledema, and visual loss in the absence of neurologic signs (except possible CN VI palsy), Hydrocephalus or intracranial masses on CT or MRI. findings without evidence of thrombosis; lumbar puncture opening pressure of >25 cmH2O; normal biochemical and cytological composition of the CSF. The overall age-adjusted and gender-adjusted annual incidence is increasing and was reported to be 2.4 per 100 000 within the last decade (2002-2014).A variety of aetiologies have been suggested to explain the pathophysiology behind IIH, including meningeal inflammation, metabolic disturbances (e.g., hyper- or hypoadrenalism and hypoparathyroidism), medication effects (e.g., excess vitamin A, corticosteroids, and tetracycline), and cerebral venous hypertension.Imaging of patients with IIH is traditionally performed to exclude lesions that produce intracranial hypertension. MR imaging features of IIH include posterior globe flattening, a protrusion of the subarachnoid space in the cavum sellae (Empty Sella), distension of the preoptic subarachnoid space, enhancement of the prelaminar optic nerve, vertical tortuosity of the orbital optic nerve, and intraocular protrusion of the prelaminar optic nerve. Although these findings support the presence of elevated ICP and, thus, the diagnosis of IIH, they are not predictive of the severity of visual loss, and their absence does not exclude the diagnosis. It should not guide a specific management of patients with IIH .
The first line of treatment for IIH consists of weight loss and/or medical therapy including diuretics such as acetazolamide. When medical treatment fails, surgical options include cerebrospinal fluid (CSF) diversion via ventriculoperitoneal (VP) or lumboperitoneal (LP) shunting or optic nerve sheath fenestration. Recently, another etiology of cerebral venous hypertension has garnered increasing attention as a putative cause of IIH, cerebral venous Dural sinus stenosis. In medically refractory IIH patients with a physiologic pressure gradient across venous stenosis, cerebral venous stenting has emerged as an alternative treatment to traditional surgical approaches.
Transverse sinus stenosis can be seen in 2 morphologic forms: an extrinsic smooth gradually narrowing tapered stenosis and intrinsic discrete obstructions, presumably due to arachnoid granulations or fibrous septae. While intrinsic transverse sinus stenosis might cause IIH by completely occluding the transverse sinus, the extrinsic compression resolves with CSF drainage. might be secondary to intracranial hypertension. Venous sinus stenting (VSS) reduces intracranial venous pressures and improves idiopathic intracranial hypertension (IIH) symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dural Venous sinus stent | Experimental | 40 Patients Diagnosed with idiopathic intracranial hypertension according to modified Dandy Criteria subjected to Dural venous sinus stenting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dural venous sinus stenting | Procedure | 40 patients with idiopathic intracranial hypertension according to Modified Dandy Criteria will subjected to Dural venous stenting |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in headache impact scale(HIT-6) | The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function. minimum score 36 and maximum score 78 | 3, 6 months |
| Papilledema Friesen grading scale | The Frisen grading system is an objective criteria used to describe the degree of papilledema, which is swelling of the optic disc from increased ICP grading from zero to 5 | 3 months and 6 months |
| Visual filed Assessment Perimetry | Perimetry is the systematic measurement of visual field function (the total area where objects can be seen in the peripheral vision while the eye is focused on a central point). | 3,6 months |
| Changes in other symptoms tinnitus, abducent nerve palsy and Transient visual Obsecuration | changes in other symptomology including tinnitus ,abducent nerve palsyand TVO | 3,6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Patency and pressure change | Diagnostic DSA follow up and measuring pressure gradient changes pre and post stenting | 6 months |
| stent Patency | in stent stenosis and Adjacent stent stenosis |
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Inclusion Criteria:
40 Patients of idiopathic intracranial hypertension subjected to Dural venous sinus stenting met the modified Dandy criteria for (IIH).
Signs and symptoms of increased intracranial pressure: Headaches, nausea, vomiting, visual changes, and papilledema.
No localizing or focal neurologic signs: Except for possible unilateral or bilateral VI nerve paresis.
Elevated cerebrospinal fluid (CSF) pressure: Without cytologic or chemical abnormalities.
No etiology for increased intracranial pressure: On neuroimaging findings.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed zayed Zayed, master degree | Contact | +201098099043 | mzayeds1206@gmai.com | |
| Ahmed Nasreldein Mohamed, PhD | Contact | +201009949677 | d_ahmednasr@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Asyut | 2063045 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39209429 | Result | Hilvert AM, Gauhar F, Longo M, Grimaudo H, Dugan J, Mummareddy N, Chitale R, Froehler MT, Fusco MR. Venous sinus stenting versus ventriculoperitoneal shunting: comparing clinical outcomes for idiopathic intracranial hypertension. J Neurointerv Surg. 2024 Nov 22;16(12):1264-1267. doi: 10.1136/jnis-2024-022174. | |
| 14872049 | Result |
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 6 months |
| Safety outcome measures | Safety outcomes of occurrences of complication: Subdural Hematoma, Subarachnoid Hemorrhage, Intracerebral hematoma puncture site complication (retroperitoneal hematoma or femoral artery aneurysm) | 10 days |
| Quality of life improvement | Quality of life measure: SF-36 for fatigue. | 3,6 months |
| McGonigal A, Bone I, Teasdale E. Resolution of transverse sinus stenosis in idiopathic intracranial hypertension after L-P shunt. Neurology. 2004 Feb 10;62(3):514-5. doi: 10.1212/wnl.62.3.514. No abstract available. |
| 15230741 | Result | Subramaniam RM, Tress BM, King JO, Eizenberg N, Mitchell PJ. Transverse sinus septum: a new aetiology of idiopathic intracranial hypertension? Australas Radiol. 2004 Jun;48(2):114-6. doi: 10.1111/j.1440-1673.2004.01269.x. |
| 28255904 | Result | Aguilar-Perez M, Martinez-Moreno R, Kurre W, Wendl C, Bazner H, Ganslandt O, Unsold R, Henkes H. Endovascular treatment of idiopathic intracranial hypertension: retrospective analysis of immediate and long-term results in 51 patients. Neuroradiology. 2017 Mar;59(3):277-287. doi: 10.1007/s00234-017-1783-5. Epub 2017 Mar 2. |
| 23883223 | Result | Saindane AM, Bruce BB, Riggeal BD, Newman NJ, Biousse V. Association of MRI findings and visual outcome in idiopathic intracranial hypertension. AJR Am J Roentgenol. 2013 Aug;201(2):412-8. doi: 10.2214/AJR.12.9638. |
| 21680652 | Result | Degnan AJ, Levy LM. Pseudotumor cerebri: brief review of clinical syndrome and imaging findings. AJNR Am J Neuroradiol. 2011 Dec;32(11):1986-93. doi: 10.3174/ajnr.A2404. Epub 2011 Jun 16. |
| 9754178 | Result | Brodsky MC, Vaphiades M. Magnetic resonance imaging in pseudotumor cerebri. Ophthalmology. 1998 Sep;105(9):1686-93. doi: 10.1016/S0161-6420(98)99039-X. |
| 28187976 | Result | Kilgore KP, Lee MS, Leavitt JA, Mokri B, Hodge DO, Frank RD, Chen JJ. Re-evaluating the Incidence of Idiopathic Intracranial Hypertension in an Era of Increasing Obesity. Ophthalmology. 2017 May;124(5):697-700. doi: 10.1016/j.ophtha.2017.01.006. Epub 2017 Feb 7. |
| 26146651 | Result | Starke RM, Wang T, Ding D, Durst CR, Crowley RW, Chalouhi N, Hasan DM, Dumont AS, Jabbour P, Liu KC. Endovascular Treatment of Venous Sinus Stenosis in Idiopathic Intracranial Hypertension: Complications, Neurological Outcomes, and Radiographic Results. ScientificWorldJournal. 2015;2015:140408. doi: 10.1155/2015/140408. Epub 2015 Jun 4. |
| 12455560 | Result | Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002 Nov 26;59(10):1492-5. doi: 10.1212/01.wnl.0000029570.69134.1b. |
| 8309269 | Result | Radhakrishnan K, Ahlskog JE, Garrity JA, Kurland LT. Idiopathic intracranial hypertension. Mayo Clin Proc. 1994 Feb;69(2):169-80. doi: 10.1016/s0025-6196(12)61045-3. |