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Trial record 3 of 31 for:    Pseudotumor Cerebri

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

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ClinicalTrials.gov Identifier: NCT02394067
Recruitment Status : Not yet recruiting
First Posted : March 20, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Jai Shankar, 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.

Condition or disease Intervention/treatment
Pseudotumor Cerebri Other: Radiological Imaging

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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetic Resonance Venography Pre- and Post-Treatment in Patients With Idiopathic Intracranial Hypertension
Study Start Date : August 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
magnetic resonance imaging and magnetic resonance venography scans




Primary Outcome Measures :
  1. Transverse venous sinus stenosis (combined conduit score, and measure of transverse venous sinus stenosis, for each MRI/MRV) [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02394067


Contacts
Contact: Jai Shankar, MD (902) 473-5446 JaiJai.Shankar@cdha.nshealth.ca
Contact: Anastasia Neufeld, MD (902) 473-2220 Anastasia.Neufeld@dal.ca

Locations
Canada, Nova Scotia
CapitalDHACanada Not yet recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Jai Dr. Jai Shankar, MD    (902) 473-5446    JaiJai.Shankar@cdha.nshealth.ca   
Contact: Anastasia Neufeld, MD    (902) 473-2220    Anastasia.Neufeld@dal.ca   
Sponsors and Collaborators
Jai Shankar
Investigators
Principal Investigator: Jai Shankar, MD Capital Health, Canada

Responsible Party: Jai Shankar, Principal Investigator Sponsor, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02394067     History of Changes
Other Study ID Numbers: 20150217
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Pseudotumor Cerebri
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases