The Food and Drug Administration (FDA) has approved a promising new clinical trial for patients suffering from pulsatile tinnitus. The trial, which will be directed by Dr. Athos Patsalides, will test the effectiveness of venous sinus stenting to relieve the symptoms of pulsatile tinnitus in patients with venous sinus stenosis.
Tinnitus is one of the most vexing of conditions, with patients hearing sounds that range from whooshing and whistling to clicking and buzzing. Some patients report the sounds only intermittently, but some hear them constantly. In mild cases tinnitus can be a minor annoyance, but in more severe cases the sounds can be truly debilitating.
More than 3 million Americans are estimated to suffer from a type of tinnitus called pulsatile tinnitus, in which the sounds are in synch with the patient’s heartbeat. The sounds are caused by a turbulence in the blood flow around the ear, and in some cases they may be a symptom of a serious underlying condition. Careful evaluation is always required to identify the underlying cause of the tinnitus.
In many cases, pulsatile tinnitus can be traced to stenosis in one of the large veins in the brain, most commonly the transverse and sigmoid sinuses. The narrowing of the veins causes a disturbance in the blood flow and leads to the pulsatile tinnitus. Some patients with severe pulsatile tinnitus have gotten relief through surgical vein ligation, but that procedure has produced mixed results along with some surgical complications. The new trial will use an endovascular approach, previously shown to be safe and effective in a trial evaluating venous sinus stenosis for idiopathic intracranial hypertension (IIH, also called pseudotumor cerebri).
In the stenting procedure, with the patient under general anesthesia Dr. Patsalides will insert a tiny, soft catheter into the femoral vein (located in the upper part of the leg) and thread it up to the affected vein in the brain. Once the catheter is in good position, Dr. Patsalides will insert a self-expanding stent into the catheter and deploy it into the narrowed segment of the vein, relieving the stenosis. This trial will test whether alleviating the stenosis eliminates the pulsatile tinnitus. The patients will be discharged within 24 hours.
Based on Dr. Patsalides’ experience with using venous sinus stenting for IIH, and on other studies showing the effectiveness of endovascular stenting, this new trial is expected to provide immediate and lasting relief of symptoms. For patients whose tinnitus is caused only by the stenosis, with no underlying condition, the stenting could essentially be a cure.
The trial will treat up to 20 patients and follow them for 24 months to evaluate the effectiveness of the procedure. The trial will begin recruiting patients when approved by the Weill Cornell Institutional Review Board (IRB).
For more information about the clinical trial, 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.
