Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Idiopathic Intracranial Hypertension Clinical Trial

Official title:

Outcome of Cerebral Venous Sinuses Stenting on Idiopathic Intracranial Hypertension

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05308823
• Other study ID #: 000046
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: September 5, 2022

Study information

• Verified date: April 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: September 5, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Idiopathic Intracranial Hypertension
• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

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

Locations

Country	Name	City	State
Egypt	Al-Azher Univerity Hospitals (Al-Hussien and Bab El-Shaeria)	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in papillodema	Frisen scale in grading of papilledema evaluation	3 months after intervention
Primary	Improvement of headache	Headache Impact Test (HIT-6) questionnaire.	3 months after intervention