Dural Venous Sinus Stent in Idiopathic Intracranial Hypertension

NCT06833424 | Not Yet Recruiting DMC

• 1 other identifier: intracranial hypertension
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to identify clinical determinants and factors that predict outcome including primary outcome and secondary outcome depending on factors in individual patients with Idiopathic intracranial hypertension treated by Dural venous sinus stenting.

Conditions

Idiopathic Intracranial Hypertension (IIH)

Keywords

predictors and outcomes

Outcome Measures

Primary Outcomes (4)

• change in headache impact scale(HIT-6)

  The Headache Impact Test (HIT) is a tool used to measure the impact headaches have on your ability to function on the job, at school, at home and in social situations. Your score shows you the effect that headaches have on normal daily life and your ability to function. minimum score 36 and maximum score 78

  3, 6 months

• Papilledema Friesen grading scale

  The Frisen grading system is an objective criteria used to describe the degree of papilledema, which is swelling of the optic disc from increased ICP grading from zero to 5

  3 months and 6 months

• Visual filed Assessment Perimetry

  Perimetry is the systematic measurement of visual field function (the total area where objects can be seen in the peripheral vision while the eye is focused on a central point).

  3,6 months

• Changes in other symptoms tinnitus, abducent nerve palsy and Transient visual Obsecuration

  changes in other symptomology including tinnitus ,abducent nerve palsyand TVO

  3,6 months

Secondary Outcomes (4)

• Stent Patency and pressure change

  6 months

• stent Patency

  6 months

• Safety outcome measures

  10 days

• Quality of life improvement

  3,6 months

Study Arms (1)

Dural Venous sinus stent

EXPERIMENTAL

40 Patients Diagnosed with idiopathic intracranial hypertension according to modified Dandy Criteria subjected to Dural venous sinus stenting

Procedure: Dural venous sinus stenting

Interventions

Dural venous sinus stenting PROCEDURE

40 patients with idiopathic intracranial hypertension according to Modified Dandy Criteria will subjected to Dural venous stenting

Dural Venous sinus stent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of idiopathic intracranial hypertension subjected to Dural venous sinus stenting met the modified Dandy criteria for (IIH).
• Signs and symptoms of increased intracranial pressure: Headaches, nausea, vomiting, visual changes, and papilledema.
• No localizing or focal neurologic signs: Except for possible unilateral or bilateral VI nerve paresis.
• Elevated cerebrospinal fluid (CSF) pressure: Without cytologic or chemical abnormalities.
• No etiology for increased intracranial pressure: On neuroimaging findings.
• Age: 18-60 years

You may not qualify if:

• Age less than or equal to 18 years.
• severe allergic reaction to iodine contrast or chronic Kidney disease.
• contraindication to general anesthesia or antiplatelet anticoagulants, Hemorrhagic Diathesis
• patients with secondary causes of intracranial hypertension: Dural arteriovenous fistula or other arteriovenous lesion affecting cortical venous flow.
• pregnancy.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Faculty of Medicine

Asyut, 2063045, Egypt

Location

Related Publications (11)

• Hilvert AM, Gauhar F, Longo M, Grimaudo H, Dugan J, Mummareddy N, Chitale R, Froehler MT, Fusco MR. Venous sinus stenting versus ventriculoperitoneal shunting: comparing clinical outcomes for idiopathic intracranial hypertension. J Neurointerv Surg. 2024 Nov 22;16(12):1264-1267. doi: 10.1136/jnis-2024-022174.

  PMID: 39209429 RESULT

• McGonigal A, Bone I, Teasdale E. Resolution of transverse sinus stenosis in idiopathic intracranial hypertension after L-P shunt. Neurology. 2004 Feb 10;62(3):514-5. doi: 10.1212/wnl.62.3.514. No abstract available.

  PMID: 14872049 RESULT

• Subramaniam RM, Tress BM, King JO, Eizenberg N, Mitchell PJ. Transverse sinus septum: a new aetiology of idiopathic intracranial hypertension? Australas Radiol. 2004 Jun;48(2):114-6. doi: 10.1111/j.1440-1673.2004.01269.x.

  PMID: 15230741 RESULT

• Aguilar-Perez M, Martinez-Moreno R, Kurre W, Wendl C, Bazner H, Ganslandt O, Unsold R, Henkes H. Endovascular treatment of idiopathic intracranial hypertension: retrospective analysis of immediate and long-term results in 51 patients. Neuroradiology. 2017 Mar;59(3):277-287. doi: 10.1007/s00234-017-1783-5. Epub 2017 Mar 2.

  PMID: 28255904 RESULT

• Saindane AM, Bruce BB, Riggeal BD, Newman NJ, Biousse V. Association of MRI findings and visual outcome in idiopathic intracranial hypertension. AJR Am J Roentgenol. 2013 Aug;201(2):412-8. doi: 10.2214/AJR.12.9638.

  PMID: 23883223 RESULT

• Degnan AJ, Levy LM. Pseudotumor cerebri: brief review of clinical syndrome and imaging findings. AJNR Am J Neuroradiol. 2011 Dec;32(11):1986-93. doi: 10.3174/ajnr.A2404. Epub 2011 Jun 16.

  PMID: 21680652 RESULT

• Brodsky MC, Vaphiades M. Magnetic resonance imaging in pseudotumor cerebri. Ophthalmology. 1998 Sep;105(9):1686-93. doi: 10.1016/S0161-6420(98)99039-X.

  PMID: 9754178 RESULT

• Kilgore KP, Lee MS, Leavitt JA, Mokri B, Hodge DO, Frank RD, Chen JJ. Re-evaluating the Incidence of Idiopathic Intracranial Hypertension in an Era of Increasing Obesity. Ophthalmology. 2017 May;124(5):697-700. doi: 10.1016/j.ophtha.2017.01.006. Epub 2017 Feb 7.

  PMID: 28187976 RESULT

• Starke RM, Wang T, Ding D, Durst CR, Crowley RW, Chalouhi N, Hasan DM, Dumont AS, Jabbour P, Liu KC. Endovascular Treatment of Venous Sinus Stenosis in Idiopathic Intracranial Hypertension: Complications, Neurological Outcomes, and Radiographic Results. ScientificWorldJournal. 2015;2015:140408. doi: 10.1155/2015/140408. Epub 2015 Jun 4.

  PMID: 26146651 RESULT

• Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002 Nov 26;59(10):1492-5. doi: 10.1212/01.wnl.0000029570.69134.1b.

  PMID: 12455560 RESULT

• Radhakrishnan K, Ahlskog JE, Garrity JA, Kurland LT. Idiopathic intracranial hypertension. Mayo Clin Proc. 1994 Feb;69(2):169-80. doi: 10.1016/s0025-6196(12)61045-3.

  PMID: 8309269 RESULT

MeSH Terms

Conditions

Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mohamed zayed Zayed, master degree

CONTACT

+201098099043; mzayeds1206@gmai.com

Ahmed Nasreldein Mohamed, PhD

CONTACT

+201009949677; d_ahmednasr@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

EG (1)