Advancements in the treatment of tinnitus may be on the horizon with the announcement of a new study funded by the National Institutes of Deafness and Other Communicable Disorders (NIDCD), a division of the National Institutes of Health (NIH). The clinical trial will study a treatment called vagus nerve stimulation (VNS) using the Serenity System device, manufactured by MicroTransponder, Inc.
Using the concept of a neural monotonic map, a pathway that sends auditory frequencies from the ear to the brain, the study will try and decrease or stop tinnitus through the stimulation of the vagus nerve. The stimulation encourages neuroplasticity through the release of neurotransmitters and prevents neurons from amplifying frequency signals being sent to the brain, thus stopping any ringing sensation. VNS has proven to be an effective treatment method in similar studies in Europe and on lab rats, and in people with epilepsy.
“This trial has the potential to open up a whole new world of tinnitus management,” says Gordon Hughes, MD, director of clinical trials at the NIDCD.
The trial will be conducted using 30 volunteers between the ages of 22 and 65 who have experienced tinnitus persistently for more than a year, and have received at least one other type of treatment for the condition. The participants will report to one of four institutions participating in the trial: the University of Buffalo, New York; the University of Iowa, Iowa City; the University of Texas at Dallas; and a fourth institution to be announced in the near future. In a double-blind study, the volunteers will be broken up into two groups; one group will receive the VNS therapy while the other will receive a placebo treatment.
During the VNS therapy, participants will receive single-frequency waves through headphones while the device stimulates the vagus nerve, reconfiguring the monotopic pathway and allowing neurons to react to their original frequencies. Each therapy session will last approximately two and a half hours, occurring over a six-week period. After those six weeks the group that received the placebo treatment will have the opportunity to receive VNS therapy for another six weeks, and then all participants will undergo audiometric testing periodically to detect any changes. If successful, this trial will be a substantial step toward finding a way to ease the symptoms of tinnitus.