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Now Enrolling: New Clinical Trial for Pulsatile Tinnitus
June 17, 2016
Weill Cornell Medicine is now enrolling patients for a new clinical trial that will evaluate the safety and efficacy of a stenting procedure to relieve the symptoms of pulsatile tinnitus in patients with significant venous sinus stenosis.
Patients who have pulsatile tinnitus experience a “whooshing” sound that is in sync with their heartbeats. The condition, which affects more than 3 million Americans, is caused by a turbulence in the blood flow around the ear.
Mild causes can be a minor annoyance but in more severe cases, the sounds can be truly debilitating. The noise can also be a symptom of a serious underlying issue, which is why physicians strongly recommend an evaluation to identify the cause of the tinnitus.
Dr. Athos Patsalides, who is conducting the trial, will treat up to 20 patients whose pulsatile tinnitus is caused by venous sinus stenosis, an abnormal narrowing in one of the large veins in the brain.
Dr. Patsalides will insert a stent in the narrowed vein to restore healthy blood flow and see if alleviating the stenosis eliminates the pulsatile tinnitus. While the patient is under general anesthesia, he will insert a tiny, soft catheter into the femoral vein in the upper part of the leg and thread it up to the affected cerebral vein. Once the catheter is in position, Dr. Patsalides will insert a self-expanding stent into the catheter and deploy it into the narrowed segment of the brain.
Patients will be discharged within 24 hours and followed for 24 months to evaluate the effectiveness of the procedure.
Data gathered over the last few years, especially from Dr. Patsalides’ current clinical trial for idiopathic intracranial hypertension (IIH) — also known as pseudotumor cerebri — provide reason for optimism about this procedure.
The new tinnitus trial will use the same endovascular approach that has been used effectively in the IIH trial. The new trial is prospective and will use strict inclusion and exclusion criteria, with long-term clinical and imaging follow up.
The trial has been approved the FDA as well as the Institutional Review Board at Weill Cornell Medicine. The trial is also listed on clinicaltrials.gov.
Who is eligible for the clinical trial?
There are two major eligibility criteria:
- Persistent severe pulsatile tinnitus despite medical or non-surgical therapies.
- Significant venous sinus stenosis on Magnetic Resonance Venography (MRV) or Computed Tomography Venography (CTV).