Venous Sinus Stenting To Treat Intractable Pulsatile Tinnitus Caused By Venous Sinus Stenosis
Tinnitus, Pulsatile Tinnitus, Venous Sinus Stenosis
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Venous Sinus Stenting, Dural Sinus Stenting
Eligibility Criteria
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
Sites / Locations
- New York Presbyterian Hospital/ Weill Cornell Medicine
Arms of the Study
Arm 1
Experimental
Venous Sinus Stenting
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. Under general anesthesia, a catheter will be inserted through a vein the upper part of the leg (groin area) and guided through the veins all the way to neck and the head. 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. After the procedure, the participants will stay in the intensive care unit for 24 hours for observation