This is an informational page for a U.S. clinical trial for the treatment of tinnitus. The trial is using a new therapy developed by MicroTransponder (www.microtransponder.com). Enrollment is now open.
The trial is supported by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health under award number U44DC010084.
The Serenity System clinical trial for the treatment of moderate to severe tinnitus is open to all U.S. residents who have had tinnitus for more than 12 months and have already tried at least one other treatment. There are 4 sites and a total of 30 patients will be enrolled. Applicants must be between the ages of 22 and 65 and live within 200 miles of one of the 4 trial sites.
This randomized clinical trial utilizes an implantable device (called the Serenity System), which will require an outpatient procedure to place the device inside your body. (the stimulator is placed in your upper chest and the lead is placed on the vagus nerve in your neck) All study participants will be implanted with the Serenity System. During the first 6 weeks, study participants will be randomly divided into two groups: one group will receive the test therapy that is potentially effective, while the other group will receive a very similar therapy that is not expected to be effective – but both groups will hear tones and receive some stimulation. The study is “double blinded,” that is, neither the audiologist nor the participant will know which group they are in. This approach helps the study to be as accurate as possible and is considered the gold standard for testing the effectiveness of health care interventions. After the initial 6-week period, all study participants will receive the potentially effective (test) version of the therapy.
If you are selected by the site for further evaluation, you will undergo audiometric testing to check your tinnitus and hearing. Additional requirements include being in generally good health and not having any significant cardiac (heart) history, and being an appropriate candidate for surgery (the surgeon will check you to make sure). You also must not be taking medications known to cause or worsen tinnitus, or medications known to interfere with brain chemicals called neuromodulators.
For more information on the therapy, click on button below.
This is only a brief description of the basic eligibility criteria. The study investigator will assess whether or not you meet all study entry criteria. Because the study has a number of visits over the course of a year, you must live within 200 miles of one of the four centers in order to be eligible.
If you believe you might meet the entry criteria and are still interested in learning more about the device and this research study, please click the button of the appropriate site and you will be contacted within a few weeks.
Below you will find contact information for the 4 sites involved in the clinical trial. Please only apply for the clinical trial if you are within 200 miles of one of the sites below. The cities are:
1) Buffalo, New York
2) Dallas, Texas
3) Iowa City, Iowa
4) Detroit, Michigan
IF YOU LIVE OUTSIDE THE U.S. OR NOT NEAR THE 4 TRIAL SITES, AND WOULD LIKE TO BE PLACED ON OUR TINNITUS UPDATE LIST – PLEASE CLICK THE BUTTON BELOW.