The Dallas Clinical Trial on Vagus Nerve Stimulation for the Treatment of Tinnitus

The purpose of this study

You have reached the University of Texas at Dallas (UTD) and UT Southwestern Medical Center (UTSW) research study: 'Clinical trial on Vagus Nerve Stimulation for the Treatment of Tinnitus'.

This website describes the study to help you decide if you want to participate in a clinical trial on Vagal Nerve stimulation for the treatment of tinnitus. This website form provides important information about what you will be asked to do during the study, about the risks and benefits of the study, and about your rights as a research subject. This is a research study. We are inviting you tinnitus suffers to participate in this study. Tinnitus is a noise (ringing, buzzing, whistling ...) in the ear(s) or head.  It is a widespread problem for which there is little effective therapy.

The purpose of this study is to investigate the effectiveness and safety of vagus nerve stimulation used with tones (the Serenity System) in the treatment of tinnitus. The vagus is one of the 12 cranial nerves (nerves that provide information between the body and brain). To prepare the vagus nerve for stimulation, you will be put to sleep for surgery. An electrode lead will be placed under the skin at the base of the neck and attached to the nerve.

If you want to learn more about Vagus Nerve Stimulation for the treatment of tinnitus you can watch this video.

The study will use the Serenity System: an implantable system developed by MicroTransponder, consisting of an implantable pulse generator, implantable lead and electrode and external controller system. Medical devices providing vagus nerve stimulation have been used and marketed for several years for the treatment of epilepsy and depression. Vagus nerve stimulation has also been used with sounds (audio-tones) in an animal model of tinnitus and this study eliminated the symptoms of tinnitus in these animals. This study hopes to learn about the effectiveness and safety of a possible treatment for tinnitus in humans. This is the second study of vagus nerve stimulation and audio-tones for the treatment of tinnitus, but this is the first study using an implanted stimulator. An earlier study in 10 patients tested this idea out using an implanted lead and external stimulation. Some people were helped with their tinnitus and some people were not helped; additionally, the prior treatment was only given for about 4 weeks so there is no long-term data available for these 10 patients on continuous use.

For the first six weeks of therapy, this study will try some subjects on the same settings tried previously, and some subjects on somewhat different settings; either way, you will receive tones and stimulation during the daily 2.5 hour therapy period. Although it is thought that one setting might be better, it is unknown which setting is better. After the first 6 weeks, everyone will be tried on similar settings that are thought to be better (more effective).

If you are interested to be involved in this study you press "continue"

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Callier Center for Communication Disorders, School of Behavioral and Brain Sciences, University of Texas at Dallas
Department of Otolaryngology-Head and Neck Surgery at UT Southwestern Medical Center
© 2013