Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Idiopathic Intracranial Hypertension
• Intervention / Treatment: Procedure: Stent

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:

  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 (7).

• Exclusion criteria included:

  1. Age less than orequal 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.
  7. 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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Mohammed Ahmed Zaki, Ass. Prof, Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): September 5, 2022

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Idiopathic Intracranial Hypertension stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypertension; Intracranial Hypertension; Pseudotumor Cerebri
• Other Study ID Numbers: 000046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All selected patients will be assessed after 3 months for headache and papilledema by (HIT-6) questionnaire in headache evaluation and Frisen scale in grading of papilledema evaluation in addition to MRV.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No