Pseudotumor CerebriNCT02394067
Magnetic Resonance Venography Pre- and Post-Treatment in Patients With Idiopathic Intracranial Hypertension
An observational study of Pseudotumor Cerebri, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pseudotumor Cerebri
- What is being tested?
- Radiological Imaging
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2015to 22 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- All patients with a diagnosis of IIH, where other intracranial pathology has been ruled out, can participate.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pseudotumor Cerebri
- Being tested
- Radiological Imaging
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiological ImagingOther
magnetic resonance imaging and magnetic resonance venography scans
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Radiological Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 MRI/MRV's performed within a year of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study start20 Apr 2015
- Primary completion25 Apr 2019
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudotumor CerebriStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jai Shankar, MD, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394067
- Sponsor's protocol ID
- 20150217
- Status last verified
- Oct 2022
- First submitted
- 16 Mar 2015
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Venography Pre- and Post-Treatment in Patients With Idiopathic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT02394067
- Acronym / sponsor ID
- 20150217
- Conditions
- Pseudotumor Cerebri
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Intracranial Hypertension | – | Other: Radiological ImagingAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients with a diagnosis of IIH, where other intracranial pathology has been ruled out, can participate.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiological Imagingmagnetic resonance imaging and magnetic resonance venography scans | Other | Idiopathic Intracranial Hypertension |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jai Shankar, MD principal investigator
Capital Health, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pseudotumor Cerebri, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.