Clinical Trial: Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial (OPEN-UP)
Brief Summary: Pseudotumor cerebri, also called idiopathic intracranial hypertension (IIH), is characterized by elevated intracranial pressure, headache, and if severe, vision loss.
IIH is difficult to treat.
Medical management may not adequately resolve the symptoms, and surgical management (primarily through cerebrospinal fluid [CSF] shunting) has a high failure rate.
Recently, a relationship between IIH and stenosis of the dural venous sinuses (the veins that drain blood from the brain) has been reported.
In patients with IIH in whom there is stenosis of one or more dural venous sinuses, placing a stent in the venous sinus may improve patients' objective symptoms (such as visual loss and papilledema) and subjective symptoms (such as headache).
This study will determine whether dural venous sinus stenting is as effective as CSF shunting (considered the standard surgical treatment) in treating IIH patients who have moderate vision loss and stenosis of the dural venous sinuses.
Detailed Summary:
Screening evaluation: Screening will include standard-of-care IIH evaluation including general medical and neurological examinations, blood chemistries, complete blood count, prothrombin time (PT),partial thromboplastin time (PTT), and pregnancy test.
Ophthalmological evaluation will include visual acuity, pellucid marginal degeneration (PMD), and optical coherence tomography (OCT).
Quality of life assessments are Headache Impact Test-6, Short Form Health Survey-36 and Visual Function Questionnaire-25 + Neuro-Ophthalmology supplement tests.
Participants must have had a recent (within 6 months of enrollment) magnetic resonance imaging (MRI) of the brain as well as a diagnostic lumbar puncture (including opening pressure, cerebrospinal fluid (CSF) cell count, CSF glucose and CSF protein), both of which are also part of the standard of care for diagnosis of IIH.
Eligible patients will undergo outpatient diagnostic venography within one month of initial IIH evaluation.
Under local anesthesia, transfemoral venous access will be obtained and a guide catheter will be placed in the right jugular bulb.
A microcatheter (Excelsior SL-10, Stryker Neurovascular) will then be advanced into the dural venous sinuses, and venography will be performed to determine the presence of any dural venous sinus stenosis.
Then, blood pressure will be transduced through the microcatheter at the following anatomic locations: Anterior superior sagittal sinus, posterior superior sagittal sinus, bilateral transverse sinuses, bilateral sigmoid sinuses and bilateral jugular bulbs.
The venous pressure gradient will be defined as the difference in pressure measurements between the anatomic locations proximal and distal to any stenotic venous sinus segment, or between the transverse and sigmoid sinuses.
A pressure gradient of ? 8 mmHg is considered sufficient for subsequent randomization.
In patients in which pressure gradient is < 8 mmHg, the patient will not be randomized.
Subsequent visits: Once a patient has met eligibility criteria and undergone randomization, treatment will occur within one month of the Neuro-Ophthalmology evaluations and within one month of diagnostic venography.
Follow-up visits will occur at post procedure prior to discharge (24 hours), two weeks, six months and one year after the index procedure.
At post-procedure follow-up, patients will undergo physical and neurological exams.
At two-week follow-up (within one week on either side), patients will undergo neurological and ophthalmological evaluations, OCT, perimetry, and visual acuity testing for safety.
While perimetry at this point will not be used for primary outcome analysis, substantial worsening in any of the above measures despite treatment will prompt consideration for treatment failure.
At six-month follow-up, subjects will undergo perimetry for primary outcome analysis, outpatient diagnostic cerebral venography, and pressure measurements identical to that of the screening evaluation (including pressure measurements at all predefined anatomical locations) within four weeks on either side of the six-month target date.
At both six-month and one-year follow-up visits, patients will complete follow-up quality of life questionnaires (HIT-6, SF-36 and VFQ-25 + Neuro-Ophthalmology supplement).These visits will also include queries regarding interim medical history, headache status, medication usage (specifically details and dose of those agents used to treat IIH or headache), and the number of IIH-related procedures each subject has undergone since the index procedure.
At one-year follow-up, the patient will undergo Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CRV) to assess patency of stented dural sinus.
Follow-up will occur within four weeks on either side of the one-year target date.
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Current Primary Outcome: PMD was chosen as a primary outcome due to its generalizability, test-retest reliability and standardization across centers, as well as its sensitivity to severity and progression of visual symptoms of IIH.
Based on previous work by the Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) investigators, we defined the upper and lower bounds of visual field loss severity for study inclusion as between -8 and -30 dB in the worst-affected eye.
The upper limit of -8 dB ensures enough baseline visual loss to consider surgical treatment and allow room for improvement, while the lower limit of -30 dB ensures that patients with severe visual loss unlikely to significantly improve with any treatment would be excluded.
PMD will be tested using Swedish Interactive Threshold Algorithm (SITA) standard 24-2 perimetry with stimulus size III.
Original Primary Outcome: PMD was chosen as a primary outcome due to its generalizability, test-retest reliability and standardization across centers, as well as its sensitivity to severity and progression of visual symptoms of IIH.
Based on previous work by the Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) investigators, we defined the upper and lower bounds of visual field loss severity for study inclusion as between -8 and -30 dB in the worst-affected eye.
The upper limit of -8 dB ensures enough baseline visual loss to consider surgical treatment and allow room for improvement, while the lower limit of -30 dB ensures that patients with severe visual loss unlikely to significantly improve with any treatment would be excluded.
PMD will be tested using Swedish Interactive Threshold Algorithm (SITA) standard 24-2 perimetry with stimulus size III.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: St. Joseph's Hospital and Medical Center, Phoenix
Dates:
Date Received: July 30, 2015
Date Started: June 03, 2020
Date Completion: January 01, 2024
Last Updated: January 19, 2024
Last Verified: January 01, 2023
