Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/26/2019 |
| Start Date: | May 2016 |
| End Date: | January 2022 |
| Contact: | Athos Patsalides, MD MPH |
| Email: | atp9002@med.cornell.edu |
| Phone: | 2127462821 |
There have been few published studies that examine the efficacy and safety of endovascular
treatments on patients with pulsatile tinnitus with venous stenosis. Despite the limited
experience with venous sinus stenting to treat pulsatile tinnitus, preliminary results show
that venous sinus stenting could represent a viable alternative for refractory pulsatile
tinnitus patients with venous sinus stenosis. The purpose of our study is to evaluate the
safety and efficacy of this procedure in a controlled fashion, using strict inclusion and
exclusion criteria, and long-term clinical and imaging follow-up. The investigators hope to
provide robust data regarding the safety and efficacy of venous sinus stenting for patients
with pulsatile tinnitus.
treatments on patients with pulsatile tinnitus with venous stenosis. Despite the limited
experience with venous sinus stenting to treat pulsatile tinnitus, preliminary results show
that venous sinus stenting could represent a viable alternative for refractory pulsatile
tinnitus patients with venous sinus stenosis. The purpose of our study is to evaluate the
safety and efficacy of this procedure in a controlled fashion, using strict inclusion and
exclusion criteria, and long-term clinical and imaging follow-up. The investigators hope to
provide robust data regarding the safety and efficacy of venous sinus stenting for patients
with pulsatile tinnitus.
WHAT IS INVOLVED IN THE STUDY?
A. Screening process - not experimental:
Patients with pulsatile tinnitus, evidence of narrowing of the large veins of the brain, and
failure of prior conservative treatment will be considered for enrollment. All patients will
undergo the standard of care evaluation for tinnitus by a specialist physician for diseases
of the ear (Ear, Nose and Throat [ENT] physician or otorhinolaryngologist). If it is
determined that the narrowing of the large veins of the brain ("dural venous sinuses") is the
most likely etiology for the tinnitus, then the possibility of enrollment in the trial will
be discussed. Imaging studies of the head and temporal bone will be performed in order to
further confirm venous sinus stenosis as the etiology of the pulsatile tinnitus and to rule
out other possible causes. Additionally, patients will answer the questions listed on the
Tinnitus Handicap Inventory questionnaire.
During the screening process, we will review the results of tests that are not experimental
and are performed as part of your routine care. In other words, these tests are performed
regardless of your participation in the study and are termed "standard procedures".
B. Participating in the study:
Participating in the trial means that the participants will undergo an experimental procedure
called "venous sinus stenting" to open up the narrowing in the vein that is causing the
tinnitus. This procedure requires taking two blood thinners called aspirin and Plavix. Both
blood thinners will be initiated 1 week prior to the procedure and continued for 1 month
after the procedure. At that time the Plavix will be stopped and aspirin will be continued
for 11 more months (total of 12 months).
- Direct Retrograde Cerebral Venography (DRCV) and Manometry: A DRCV is a non-experimental
procedure to look at the veins of the brain. This procedure is done by inserting a catheter
(soft plastic tube) through a vein in the groin (upper leg) and guide it though the veins all
the way to the neck. It is done under local anesthetic and moderate sedation. After placing
the catheter in the neck, a special dye (contrast) is injected through this catheter into the
veins, while X-ray cameras take multiple pictures of the veins. Then, a smaller catheter is
further advanced to the area of narrowing and by this catheter we will measure the blood
pressure at that point. This helps us to identify the severity of the narrowing. If the
pressure before and after the narrowing is significantly different, than we will continue
with the placement of the stent in order to reopen the narrowing.
- Venous Sinus Stenting (experimental): Venous sinus stenting is the experimental procedure
being tested in this protocol and consists of placing a stent into the narrowed veins of the
brain. The participants will be placed under general anesthesia because it is important that
you do not move at all during the procedure. A catheter will be inserted through the upper
part of the leg (groin area) and guided through the veins all the way to neck. Then, a
balloon will be advanced through the catheter and positioned across the stenosis. The balloon
will be carefully inflated for a few seconds. This process is called angioplasty and will
partially re-open the narrowing, making placement of the stent easier. The balloon will be
removed and then the stent will be advanced through the catheter in neck across the stenosis
and carefully deployed.
- Post-procedure Care: After the procedure, you will stay in the intensive care unit for 24
hours for observation.
C. Follow-up period:
There will be no experimental procedure or test during the follow-up period. The following
office visits and standard tests will be performed to evaluate the effects of the study
intervention.
- Office visits: Office visits and neurological evaluation will be performed at 1, 6, 12, and
24 months after study intervention. At this time, patients will also fill the Tinnitus
Handicap Inventory Questionnaire. The visits will be about 45min.
- Audiometric assessment: An audiometric assessment will be performed at 3 months after the
stenting procedure in order to assess inner ear function.
- Non-invasive imaging studies: Magnetic Resonance Venogram (MRV) is a special Magnetic
Resonance Imaging (MRI) scan with injection of a dye through a vein in the arm that will
allow us to check whether the stent is still open without new narrowing. It will be performed
12 months after the venous sinus stenting procedure. If there is clinical concern about stent
patency, an expedited or intermediate MRV will be performed. If MRV is contraindicated,
Computed Tomographic Venogram (CTV) will be performed instead.
D. Medications:
For the purpose of the study, the participants need to take antiplatelet drugs ("blood
thinners") that are necessary to prevent formation of clot in the stent. This is a standard
precaution for every stent procedure. The participants will take two drugs (called aspirin
and Plavix) for 1 month and then aspirin alone for 11 more months (total time on aspirin is
12 months). It is essential that the drugs are taken every day as prescribed. As these drugs
are dangerous during pregnancy, if the participant is a woman of childbearing age, then
should discuss this issue with her physician, and avoid becoming pregnant during the 12
months that you need these drugs.
A. Screening process - not experimental:
Patients with pulsatile tinnitus, evidence of narrowing of the large veins of the brain, and
failure of prior conservative treatment will be considered for enrollment. All patients will
undergo the standard of care evaluation for tinnitus by a specialist physician for diseases
of the ear (Ear, Nose and Throat [ENT] physician or otorhinolaryngologist). If it is
determined that the narrowing of the large veins of the brain ("dural venous sinuses") is the
most likely etiology for the tinnitus, then the possibility of enrollment in the trial will
be discussed. Imaging studies of the head and temporal bone will be performed in order to
further confirm venous sinus stenosis as the etiology of the pulsatile tinnitus and to rule
out other possible causes. Additionally, patients will answer the questions listed on the
Tinnitus Handicap Inventory questionnaire.
During the screening process, we will review the results of tests that are not experimental
and are performed as part of your routine care. In other words, these tests are performed
regardless of your participation in the study and are termed "standard procedures".
B. Participating in the study:
Participating in the trial means that the participants will undergo an experimental procedure
called "venous sinus stenting" to open up the narrowing in the vein that is causing the
tinnitus. This procedure requires taking two blood thinners called aspirin and Plavix. Both
blood thinners will be initiated 1 week prior to the procedure and continued for 1 month
after the procedure. At that time the Plavix will be stopped and aspirin will be continued
for 11 more months (total of 12 months).
- Direct Retrograde Cerebral Venography (DRCV) and Manometry: A DRCV is a non-experimental
procedure to look at the veins of the brain. This procedure is done by inserting a catheter
(soft plastic tube) through a vein in the groin (upper leg) and guide it though the veins all
the way to the neck. It is done under local anesthetic and moderate sedation. After placing
the catheter in the neck, a special dye (contrast) is injected through this catheter into the
veins, while X-ray cameras take multiple pictures of the veins. Then, a smaller catheter is
further advanced to the area of narrowing and by this catheter we will measure the blood
pressure at that point. This helps us to identify the severity of the narrowing. If the
pressure before and after the narrowing is significantly different, than we will continue
with the placement of the stent in order to reopen the narrowing.
- Venous Sinus Stenting (experimental): Venous sinus stenting is the experimental procedure
being tested in this protocol and consists of placing a stent into the narrowed veins of the
brain. The participants will be placed under general anesthesia because it is important that
you do not move at all during the procedure. A catheter will be inserted through the upper
part of the leg (groin area) and guided through the veins all the way to neck. Then, a
balloon will be advanced through the catheter and positioned across the stenosis. The balloon
will be carefully inflated for a few seconds. This process is called angioplasty and will
partially re-open the narrowing, making placement of the stent easier. The balloon will be
removed and then the stent will be advanced through the catheter in neck across the stenosis
and carefully deployed.
- Post-procedure Care: After the procedure, you will stay in the intensive care unit for 24
hours for observation.
C. Follow-up period:
There will be no experimental procedure or test during the follow-up period. The following
office visits and standard tests will be performed to evaluate the effects of the study
intervention.
- Office visits: Office visits and neurological evaluation will be performed at 1, 6, 12, and
24 months after study intervention. At this time, patients will also fill the Tinnitus
Handicap Inventory Questionnaire. The visits will be about 45min.
- Audiometric assessment: An audiometric assessment will be performed at 3 months after the
stenting procedure in order to assess inner ear function.
- Non-invasive imaging studies: Magnetic Resonance Venogram (MRV) is a special Magnetic
Resonance Imaging (MRI) scan with injection of a dye through a vein in the arm that will
allow us to check whether the stent is still open without new narrowing. It will be performed
12 months after the venous sinus stenting procedure. If there is clinical concern about stent
patency, an expedited or intermediate MRV will be performed. If MRV is contraindicated,
Computed Tomographic Venogram (CTV) will be performed instead.
D. Medications:
For the purpose of the study, the participants need to take antiplatelet drugs ("blood
thinners") that are necessary to prevent formation of clot in the stent. This is a standard
precaution for every stent procedure. The participants will take two drugs (called aspirin
and Plavix) for 1 month and then aspirin alone for 11 more months (total time on aspirin is
12 months). It is essential that the drugs are taken every day as prescribed. As these drugs
are dangerous during pregnancy, if the participant is a woman of childbearing age, then
should discuss this issue with her physician, and avoid becoming pregnant during the 12
months that you need these drugs.
Inclusion Criteria:
- Severe or catastrophic venous pulsatile tinnitus defined as Grades 4 or 5 on Tinnitus
Handicap Inventory
- 50% or more stenosis of the lateral venous sinus on Magnetic Resonance Venogram (MRV)
or Computed Tomographic Venogram (CTV_, ipsilateral to the side of more severe
tinnitus
- Failure of conservative or non-surgical therapies (including sound therapy, sound
masking, hearing aids, tinnitus retraining (desensitization) therapy. Failure is
defined as Grades 4 or 5 on the Tinnitus Handicap Inventory despite prior treatments
that have lasted for at least 3 months.
Exclusion Criteria:
- Non-pulsatile tinnitus
- Contra-indication to iodinated contrast
- Contra-indication to antiplatelet therapy
- Contra-indication to general anesthesia
- Pregnancy or plans for immediate pregnancy
We found this trial at
1
site
New York, New York 10065
Phone: 212-746-2821
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