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

Pseudotumor Cerebri Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02394067
• Other study ID #: 20150217
• Status: Not yet recruiting
• Phase: N/A
• First received: March 16, 2015
• Last updated: July 27, 2015
• Start date: June 2015
• Est. completion date: September 2017

Study information

• Verified date: July 2015
• Source: Nova Scotia Health Authority
• Contact: Jai Shankar, MD
• Phone: (902) 473-5446
• Email: JaiJai.Shankar[@]cdha.nshealth.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intracranial Hypertension
• Pseudotumor Cerebri

Intervention

Other:
• Radiological Imaging
magnetic resonance imaging and magnetic resonance venography scans

Locations

Country	Name	City	State
Canada	CapitalDHACanada	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Jai Shankar

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No