Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Study Overview
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Brief Summary
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The aim of the work is to asses the positive effect of stenotic sinus segment stenting on idiopathic intracranial hypertension with headache and papilloedema.

Detailed Description
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Participants The study will include group of patients with an established diagnosis of idiopathic intracranial hypertenton meeting our inclusion criteria and will admitted to Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria) after informed consent from them. The recruitment will take place after approval from the Ethics Committee and the University Council. They are selected according to The modified Dandy Criteria to Diagnose IIH: Grade II paplledema . normal neurological examination except for six nerve palsy. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI. normal CSF composition. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults (7). Exclusion criteria included: Age less than orequal to 18 years. creatinine .1.5 mg/dL. severe allergic reaction to iodine contrast. contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow. pregnancy. Blood pressure must be measured to exclude malignant hypertension, as defined as a diastolic blood pressure greater than or equal to 120 mm Hg or systolic blood pressure greater than or equal to 180 mm Hg(17).

Official Title
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Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Conditions
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Idiopathic Intracranial Hypertension

Intervention / Treatment
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* Procedure: Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Grade II paplledema . 2. normal neurological examination except for six nerve palsy. 3. neuroimaging criteria of normal brain parenchyma without evidence of hydrocephalus, mass or structural lesion and no abnormal meningeal enhancement on MRI. 4. normal CSF composition. 5. elevated lumbar puncture opening pressure, defined as greater than or equal to 250 mmH2O in adults Exclusion Criteria: 1. Age less than to 18 years. 2. creatinine .1.5 mg/dL. 3. severe allergic reaction to iodine contrast. 4.contraindication to general anesthesia, use of aspirin, clopidogrel or anticoagulants, thrombophilic disorder or anticardiolipin syndrome. 5. dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow. 6. pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1<br>The paients in this group will receive traditional treatment of IIH for 3 months. | |
| Experimental: Group 2<br>The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent. | Procedure: Stent<br>* The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent<br>* Other names: Venous sinus stenting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in papillodema | Frisen scale in grading of papilledema evaluation | 3 months after intervention | 
| Improvement of headache | Headache Impact Test (HIT-6) questionnaire. | 3 months after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idiopathic Intracranial Hypertension stenting