The trial is supported by the National Institute on Deafness and Other Communication Disorders (NIDCD), which is part of the National Institutes of Health. The trial is being conducted through a cooperative agreement with Dallas-based medical device maker MicroTransponder Inc., and participants include UT Southwestern, University of Texas at Dallas, and universities in New York and Iowa.
“We are excited to be testing this new avenue for tinnitus treatment because current therapies lack the potential to significantly reduce the bothersome symptoms of tinnitus,” said Dr. Teresa Chan, Assistant Professor of Otolaryngology – Head and Neck Surgery at UT Southwestern, who will perform the implant surgeries for the Dallas arm of the trial.
Roughly 10 percent of the adult population of the United States has experienced tinnitus lasting at least five minutes in the past year, with approximately 10 million of those seeking medical attention. For some, the relentless ringing causes fatigue, depression, anxiety, and problems with memory and concentration.
Most cases of chronic tinnitus are preceded by hearing loss due to damage to the inner ear, which causes false signals to the brain, creating the illusion of sound when there is none. Research suggests that tinnitus might be the result of the brain trying to regain the ability to hear lost frequencies by turning up the signals of neurons in neighboring frequencies, so the new therapy is designed to redirect brain signaling.
The new study uses a technique known as vagus nerve stimulation (VNS), which takes advantage of the brain’s ability to reconfigure itself, called neuroplasticity. During the therapy, patients wear headphones and hear a series of single frequency tones, paired with stimulation to the vagus nerve, a large nerve that runs from the head and neck to the abdomen. When stimulated, the vagus nerve releases acetylcholine, norepinephrine, and other chemicals that encourage neuroplasticity.
In an earlier NIDCD-funded study using a rat model, the technique was shown to reorganize neurons to respond to their original frequencies, subdue their activity, and reduce their synchronous firing, suggesting that the ringing sensation had stopped. The scientists subsequently tested a prototype device in a small group of human volunteers in Europe and observed encouraging results.
“Tinnitus affects nearly 24 million adult Americans,” said James F. Battey, Jr., M.D., Ph.D., director of the NIDCD. “It is also the number one service-connected disability for returning veterans from Iraq and Afghanistan. The kind of nervous system stimuli used in this study has already been shown to safely and effectively help people with epilepsy or depression. This therapy could offer a profoundly better way to treat tinnitus.”
For this new study, two groups of adults who have had moderate-to-severe tinnitus for at least one year will participate in daily 2.5 hour sessions of VNS and audio tone therapy over six weeks. More information about the trial and enrollment is available on the study’s website, www.tinnitustrial.com, or at ClinicalTrials.gov (NCT01962558). The research is supported by NIDCD grant U44DC010084. Additional support for the UT Dallas research is provided by the Texas Biomedical Device Center.
UT Southwestern’s ear, nose, and throat (ENT) service is recognized as one of the nation’s leading clinical and research centers for audiology and cochlear implantation, balance and facial nerve disorders, head and neck cancer, skull base surgery, sleep disorders, voice and swallowing disorders, and other specialties. UT Southwestern’s ENT service was listed among high performers in U.S. News & World Report’s 2013-2014 annual report on the nation’s best hospitals.
About UT Southwestern Medical Center
UT Southwestern, one of the premier academic medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty includes many distinguished members, including five who have been awarded Nobel Prizes since 1985. Numbering more than 2,700, the faculty is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide medical care in 40 specialties to nearly 91,000 hospitalized patients and oversee more than 2 million outpatient visits a year.
Media Contact: Russell Rian