Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

NCT05308823 | Unknown

• 1 other identifier: 000046
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Intracranial Hypertension

Keywords

Idiopathic Intracranial Hypertension stenting

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1

NO INTERVENTION

The paients in this group will receive traditional treatment of IIH for 3 months.

Group 2

EXPERIMENTAL

The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent.

Procedure: Stent

Interventions

Stent PROCEDURE

The patients in this group will receive traditional treatment of IIH for 3 months in addition to venus sinus stent

Also known as: Venous sinus stenting

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)

Cairo, Egypt

Location

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Stents

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Mohammed Ahmed Zaki, Ass. Prof

  Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: April 4, 2022
• Study Start: March 15, 2022
• Primary Completion: July 15, 2022
• Study Completion: September 5, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)