Magnetic Resonance Venography Pre- and Post-Treatment in Patients With Idiopathic Intracranial Hypertension

Completed

• Conditions: Pseudotumor Cerebri
• Interventions: Other: Radiological Imaging

• Registration Number: NCT02394067
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

This prospective study will use magnetic resonance imaging of patients with Idiopathic Intracranial Hypertension (IIH), to determine if the common radiological finding of transverse venous sinus stenosis can be reversed with standard of care medical treatment of IIH.

Detailed Description

Patients with suspected Idiopathic Intracranial Hypertension (IIH) will be recruited and undergo an ophthalmologic investigation, and a lumbar puncture, both of which are necessary for diagnosis of IIH. MRI is done as a standard of care to rule out other etiologies of raised intracranial pressure. Our patients will require four MRI/MRVs. The first MRI/MRV is standard of care scan. The second MRI/MRV will be on the day of the lumber puncture, immediately following the procedure. The third MRI/MRV will take place when significant reduction of clinical papilledema has taken place (about 3-6 months), and a forth MRI will take place one year after the initial presentation or with symptom resolution, whichever comes first. Radiological findings will be compared at all stages to determine if transverse venous sinus stenosis can be reversed with standard of care medical treatment.

Study Timeline

• Study First Submitted: 2015-03-16
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-20
• Study Start: 2015-04-20
• Primary Completion: 2019-04-25
• Study Completion: 2020-10-22
• Status Verified: 2022-10
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

All patients with a diagnosis of IIH, where other intracranial pathology has been ruled out, can participate.

Exclusion Criteria

(1)Patients who have a contraindication or are unable to undergo magnetic resonance imaging. (2)Patients who are found to have intracranial pathology to explain elevated intracranial pressure. (3)Patients with allergies to gadolinium-containing agents.(4)Patients with elevated creatinine above normal laboratory values.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idiopathic Intracranial Hypertension	Radiological Imaging	All participants of our study will be in this arm. These will be patients with a diagnosis of IIH. These patients will be followed throughout their standard of care treatment, with neuro-radiological imaging.

Primary Outcome Measures

Name	Time	Method
Transverse venous sinus stenosis (combined conduit score, and measure of transverse venous sinus stenosis, for each MRI/MRV)	4 MRI/MRV's performed within a year of diagnosis	The main outcome measure will be a combined conduit score, and measure of transverse venous sinus stenosis, for each MRI/MRV.

Trial Locations

Locations (1)

CapitalDHACanada; 🇨🇦 Halifax, Nova Scotia, Canada