Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Al-Azhar University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improvement of headache
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. 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
Exclusion Criteria
- •1. Age less than to 18 years.
- •creatinine .1.5 mg/dL.
- •severe allergic reaction to iodine contrast. 4.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.
Arms & Interventions
Group 1
The paients in this group will receive traditional treatment of IIH for 3 months.
Group 2
The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent.
Intervention: Stent (Procedure)
Outcomes
Primary Outcomes
Improvement of headache
Time Frame: 3 months after intervention
Headache Impact Test (HIT-6) questionnaire.
Change in papillodema
Time Frame: 3 months after intervention
Frisen scale in grading of papilledema evaluation
Secondary Outcomes
No secondary outcomes reported
Investigators
Alwathekbellah Ihab Ahmed Elsayed
Doctor
Al-Azhar University
