New Tinnitus Treatment Device Developed By Dallas-Based MicroTranspoonder To Be Tested In NIH Clinical Trial
Posted by: Sreetama Dutt March 11, 2014
The National Institute of Deafness and other Communicable Disorders ( NIDCD) recently granted funding for a clinical trial that will seek to find a therapeutic cure for Tinnitus, which causes a persistent buzzing sound in the ear. The grant (U44DC010084) from the National Institutes of Health (NIH) will support new research, which is being conducted with the help of a co-operative agreement with Dallas-based medical device company MicroTransponder, and will seek to test new methods in treating the condition.
Tinnitus is a condition which affects around 24 million Americans, with 10% of the patient population presenting with a persistent ringing sound that lasts for 5 minutes or more, and about 10 million patients who are afflicted enough to seek medical treatment. It is a condition which develops with aging, and is the leading cause of disability in veterans returning from Iraq and Afghanistan.
In recent years, scientists have worked to better understand the what causes tinnitus. Hearing impairment occurs when the sensory cells of the inner ear get damaged and hence they cannot transmit nerve impulses to the brain. A monotonic map, which traces the auditory pathway from the ears to the brain, has been created part of ongoing research into the condition. This pathway (which is currently just a concept) consists of nerves (neurons) transmitting sound waves of various frequencies to the brain in the form of signals. Due to hearing impairment, certain frequencies are not processed by these neurons, and hence the brain does not receive them. This condition corresponds to the distortion patterns of neurons in the auditory cortex. The brain then tries to regain these frequencies by amplifying the signals of the neighboring neurons, which in turn results in them responding more strongly leading to persistent ringing or the wheezing sounds.
The technique used in this regard is the Vagus Nerve Stimulation (VNS) technique — a technique confirmed as safe and effective by UT Dallas researchers previously — with the help of the “Serenity System.” Here, patients are given headphones with a series of single frequency waves being fed in, paired with stimulation to the vagus nerve (extending from the head to the abdomen). These signals encourage the release of neurotransmitters (acetylcholine, norepinephrine, etc.) that encourage neuroplasticity, which are then processed by the brain.
A similar test has been performed earlier in rats, which made them respond to their original frequencies, reduced synchronous firing, and simultaneously reduced the ringing sensation. A prototype of this device was used effectively in a small group of European patients as well, and was found to have a positive effect on epileptic patients as well.
The NIH aims to hire around 30 volunteers in a total of 4 sites including The University of Buffalo, New York, The University of Texas at Dallas, The University of Iowa, Iowa City and a fourth location which is yet to be disclosed. The volunteers should live within a 200 mile radius of these centers, be between ages 22 and 65, with a persisting condition of tinnitus for more than a year, with a more or less stable health condition, and without cardiac abnormalities. The VNS therapy would last for 2.5 hours, with two phases — the first one being a double blind clinical trial with a placebo, lasting for 6 weeks, after which all volunteers would be treated with effective treatment with potential of curing tinnitus. After patients clear this phase, they will undergo audiometric testing, lasting for more than 6 weeks.
According to NIDCD’s Gordon Hughes, “This trial has the potential to open up a whole new world of tinnitus management. 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.”
Adding to this, the CEO of MicroTransponder Inc. Frank McEachern, said: “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.”
If successful, this would provide a much needed relief to the elderly and veterans alike, improving their hearing ability from within and eliminating the need for the bothersome hearing aids.