Pilot Clinical Trial of Deep Brain Stimulation for Tinnitus

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DESCRIPTION (provided by applicant): Tinnitus is a phantom auditory disorder that affects 10-15% of the general population. In the absence of external sounds, there is constant ringing, hissing, buzzing, roaring and other sounds localized to one or both ears. The problem is growing because injurious noise exposure in baby boomers and military personnel can often trigger symptoms. Whereas most patients with chronic tinnitus will largely ignore their acoustic sensation, some will have emotional reactions to their auditory phantom and suffer from impairments in sleep, mood, and activities of daily living. Thirteen million with tinnitus in the U and Europe seek medical attention. Over 1 million suffer from unremitting symptoms that are refractory to established treatments, such as hearing aids, neurobehavioral sound extinction procedures, and magnetic or electrical stimulation of auditory cortex. Those tinnitus sufferers have little therapeutic recourse. A potential new treatment for chronic tinnitus is to block tinnitus-related brain activity from reaching brain centers that reinforce adverse behavioral reactions to the auditory phantom. By applying deep brain stimulation (DBS) to area LC of the caudate nucleus, pathological neural activity with perceptual consequences will either be eliminated or ignored. We propose a pilot clinical trial of DBS in area LC in adults with a big or very big problem with chronic tinnitus. The specific aims of this project are: 1) to estimate the treatment effect size of DBS in area LC on tinnitus severity, and 2) assess preliminary safety and tolerability of DBS in area LC.