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

NCT02394067 | Completed

• 1 other identifier: 20150217
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudotumor Cerebri

Outcome Measures

Primary Outcomes (1)

• Transverse venous sinus stenosis (combined conduit score, and measure of transverse venous sinus stenosis, for each MRI/MRV)

  The main outcome measure will be a combined conduit score, and measure of transverse venous sinus stenosis, for each MRI/MRV.

  4 MRI/MRV's performed within a year of diagnosis

Study Arms (1)

Idiopathic Intracranial Hypertension

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.

Other: Radiological Imaging

Interventions

Radiological Imaging OTHER

magnetic resonance imaging and magnetic resonance venography scans

Idiopathic Intracranial Hypertension

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the neuro-ophthalmology service at the Queen Elizabeth II Health Center. Neuro-ophthalmology service in Nova Scotia sees approximately 20 new diagnoses of IIH per year.

You may qualify if:

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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

CapitalDHACanada

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Postmortem Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques

Study Officials

• Jai Shankar, MD

  Capital Health, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: April 20, 2015
• Primary Completion: April 25, 2019
• Study Completion: October 22, 2020
• Last Updated: August 21, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)