[HEALTH.MIL] NIH Announces Recruitment For Clinical Trial To Test New Tinnitus Treatment Device

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  • Date: Thu, 6 Mar 2014 20:06:41 -0600

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NIH announces recruitment for clinical trial to test new tinnitus treatment

Multi-center trial offers hope for millions of Americans with severe tinnitus


Researchers supported by the National Institutes of Health are launching a
clinical trial to test a device that uses nervous system stimuli to rewire parts
of the brain, in hopes of significantly reducing or removing tinnitus, a
persistent buzzing or ringing sound in the ears in the absence of any real

An illustration showing new tinnitus treatment

This illustration shows how the new device to treat tinnitus will operate.


The small clinical trial, which is recruiting volunteers, is being conducted at
four centers through a cooperative agreement with MicroTransponder, Inc., a
medical device company based in Dallas.


Roughly 10 percent of the adult population of the United States has experienced
tinnitus lasting at least five minutes in the past year, and approximately 10
million of them have been bothered enough by the condition to seek a doctor.
Although tinnitus may be only an annoyance for some, for others the relentless
ringing causes fatigue, depression, anxiety, and problems with memory and
concentration. Available treatments help some people cope, but current therapies
lack the potential to significantly reduce the bothersome symptoms of tinnitus. 


The trial, supported by the National Institute on Deafness and Other
Communication Disorders (NIDCD), a part of NIH, may mark the beginning of a
change in how tinnitus is treated.


"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."


Most cases of chronic tinnitus are preceded by a loss of hearing as the result
of damage to the inner ear from aging, injury, or long-term exposure to loud
noise. When sensory cells in the inner ear are damaged, the resulting hearing
loss changes some of the signals sent from the ear to neurons in the auditory
cortex of the brain. Scientists still haven't agreed upon what happens to create
the illusion of sound when there is none, but the therapy being tested in this
new clinical trial attempts to ameliorate the phantom sound of tinnitus by going
to its source - the brain.


The auditory pathway is organized by what scientists call the tonotopic map, a
structural arrangement in which different tone frequencies are transmitted
separately along specific parts of the pathway. Hearing loss is the result of a
loss in the ability of the auditory system to process certain frequencies.
Earlier studies showed that the loss of the ability to hear these frequencies
matched patterns of distortion in the neurons of the auditory cortex's tonotopic


This research suggests that tinnitus might be the result of the brain trying to
regain the ability to hear those lost frequencies by turning up the signals of
neurons in neighboring frequencies. Because there are too many neurons
processing the same frequencies, they fire more strongly, more frequently and in
concert with each other, even when the environment is quiet. It is these
changing brain patterns that researchers believe could produce the perception of
whooshing, ringing, or buzzing in the ear that characterizes tinnitus.


The new study uses a technique known as vagus nerve stimulation (VNS) that takes
advantage of the brain's ability to reconfigure itself (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


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.


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.  One group will get the VNS and tone
test treatment immediately; the other will get a combination of VNS and tones
that is not expected to have a therapeutic benefit. After six weeks, both groups
will receive active test treatment.


Outcomes will be measured throughout the year-long trial using the Tinnitus
Functional Index and the Tinnitus Handicap Questionnaire, two questionnaires
that allow patients to report on the extent of their tinnitus. They will also be
tested periodically to determine changes in minimum masking levels for the
tinnitus - the decibel level of sound required to eliminate awareness of the


"This trial has the potential to open up a whole new world of tinnitus
management," says Gordon Hughes, M.D., director of clinical trials at the NIDCD.
"Currently, we usually offer patients a hearing aid if they have hearing loss or
a masking device if they don't. None of these treatments cures tinnitus. But
this new treatment offers the possibility of reducing or eliminating the
bothersome perception of tinnitus in some patients."


The clinical trial sites are at the University of Texas at Dallas; University at
Buffalo (SUNY), Buffalo; and the University of Iowa, Iowa City. An additional
site will be added later in the year. 



NOTE:  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.



More information about the trial and enrollment is available on the study's
website,  <http://www.tinnitustrial.com/> http://www.tinnitustrial.com
<http://www.nih.gov/exitdisclaimer.html> External Web Site Policy, or at
http://www.ClinicalTrials.gov (NCT01962558).


"The support of the NIDCD has been essential to bringing this novel tinnitus
therapy into the clinic," said MicroTransponder, Inc. CEO Frank McEachern. "The
translation of scientific discovery into medical therapies is a long and
difficult path. The NIH recognized the importance of our tinnitus research early
on, which enabled us to secure additional private funding for the extensive
development effort required to build a device for clinical trials."


The research is supported by NIDCD grant U44DC010084. Additional support for the
University of Texas at Dallas research is provided by the Texas Biomedical
Device Center.


For more information about tinnitus, see our fact sheet at


NIDCD supports and conducts research and research training on the normal and
disordered processes of hearing, balance, taste, smell, voice, speech, and
language and provides health information, based upon scientific discovery, to
the public. For more information about NIDCD programs, see the website at
<http://www.nidcd.nih.gov/> http://www.nidcd.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical
research agency, includes 27 Institutes and Centers and is a component of the
U.S. Department of Health and Human Services. NIH is the primary federal agency
conducting and supporting basic, clinical, and translational medical research,
and is investigating the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit
<http://www.nih.gov/> www.nih.gov.


NIH...Turning Discovery Into HealthR



SOURCE:   NIH news release at




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