New Clinical Trial for Pulsatile Tinnitus

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Dr. Athos Patsalides will conduct a clinical trial for tinnitus
05-13-2016

Now enrolling. Please call 212-746-2821 for more information.
The Weill Cornell Institutional Review Board (IRB) has approved a new clinical trial for pulsatile tinnitus. The trial, to be conducted by Dr. Athos Patsalides, will enroll patients with pulsatile tinnitus whose symptoms are caused by venous sinus stenosis. This clinical trial will evaluate the safety and efficacy of venous sinus stenting in patients with pulsatile tinnitus and significant venous sinus stenosis.

Dr. Patsalides is now enrolling patients in new clinical trial for pulsatile tinnitus

Pulsatile tinnitus, in which the sounds are in synch with the patient’s heartbeat, affects more than 3 million Americans. The whooshing sounds are caused by a turbulence in the blood flow around the ear, and patients must be evaluated to identify the underlying cause of the tinnitus.

This illustration shows bilateral venous sinus narrowing (red circles). As a result of the bilateral narrowing, the blood flow from the brain to the neck is disrupted, contributing to the whooshing sounds of pulsatile tinnitus.

This new trial will treat patients in whom the cause of pulsatile tinnitus has been determined to be stenosis in one of the large veins in the brain (most commonly the transverse and sigmoid sinuses). This narrowing of the veins causes a disturbance in the blood flow and leads to the pulsatile tinnitus. Inserting a stent in the narrowed vein can restore healthy blood flow and reduce or eliminate the pulsatile tinnitus.

In the stenting procedure, with the patient under general anesthesia Dr. Patsalides inserts a tiny, soft catheter into the femoral vein (located in the upper part of the leg) and threads it up to the affected vein in the brain. Once the catheter is in position, Dr. Patsalides inserts a self-expanding stent into the catheter and deploys it into the narrowed segment of the vein. This trial will test whether alleviating the stenosis eliminates the pulsatile tinnitus. The patients will be discharged within 24 hours.

Dr. Athos Patsalides with tinnitus patient Kate Metzler. Read Kate's story here.

Data gathered over the last few years, especially from Dr. Patsalides’ current clinical trial for idiopathic intracranial hypertension (IIH, also called pseudotumor cerebri), provide reason for optimism about this procedure for patients with pulsatile tinnitus. The new trial tinnitus will use the same endovascular approach that has been used effectively in the IIH trial. The new tinnitus clinical trial is prospective and will use strict inclusion and exclusion criteria, with long-term clinical and imaging follow-up.

The new clinical trial has now been approved by the FDA and the IRB at Weill Cornell Medical College and has been listed on clinicaltrials.gov. 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).

The trial will treat up to 20 patients with venous sinus stenting to alleviate the stenosis and follow them for 24 months to evaluate the effectiveness of the procedure. 

For more information about the clinical trial for pulsatile tinnitus, please contact Dr. Patsalides at 212-746-2821 or atp9002@med.cornell.edu, or use our online form to request an appointment or refer a patient.
See related news article about the FDA's approval of the clinical trial

Find out more about the  clinical trial for idiopathic intracranial hypertension.