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      Feasibility and Safety of Transcutaneous Vagus Nerve Stimulation Paired with Notched Music Therapy for the Treatment of Chronic Tinnitus

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          Abstract

          Background and Objectives

          A recent study demonstrated that tinnitus could be eliminated by vagus nerve stimulation (VNS) paired with notched sounds in a rat tinnitus model. The aims of this clinical study were to investigate the effects and safety of transcutaneous VNS (tVNS) by patch-type electrode paired with notched music for treating chronic tinnitus.

          Subjects and Methods

          Thirty patients with refractory chronic tinnitus for >12 months were included in this study. A patch-type electrode was attached to the auricular concha of the patient's left ear and tVNS was performed for 30 min (pulse rate 25 Hz, pulse width 200 µs, and amplitude 1-10 mA) using a transcutaneous electric nerve stimulation eco2. During tVNS, the patients listened to notched music cleared of the frequency spectrum corresponding to the tinnitus with a 0.5 octave notch width.

          Results

          After 10 treatment sessions, 15/30 patients (50%) reported symptom relief in terms of a global improvement questionnaire. The mean tinnitus loudness (10-point scale) and the mean tinnitus awareness score (%) improved significantly from 6.32±2.06 to 5.16±1.52 and from 82.40±24.37% to 65.60±28.15%, respectively (both p<0.05). None of the patients had any specific side effects, such as changes in heart rate or blood pressure.

          Conclusions

          This study has demonstrated the feasibility and safety of tVNS paired with notched music therapy in patients with chronic tinnitus, with the use of a pad-type electrode attached to the auricular concha.

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          Most cited references31

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          Cortical map reorganization enabled by nucleus basalis activity.

          Little is known about the mechanisms that allow the cortex to selectively improve the neural representations of behaviorally important stimuli while ignoring irrelevant stimuli. Diffuse neuromodulatory systems may facilitate cortical plasticity by acting as teachers to mark important stimuli. This study demonstrates that episodic electrical stimulation of the nucleus basalis, paired with an auditory stimulus, results in a massive progressive reorganization of the primary auditory cortex in the adult rat. Receptive field sizes can be narrowed, broadened, or left unaltered depending on specific parameters of the acoustic stimulus paired with nucleus basalis activation. This differential plasticity parallels the receptive field remodeling that results from different types of behavioral training. This result suggests that input characteristics may be able to drive appropriate alterations of receptive fields independently of explicit knowledge of the task. These findings also suggest that the basal forebrain plays an active instructional role in representational plasticity.
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            Reversing pathological neural activity using targeted plasticity.

            Brain changes in response to nerve damage or cochlear trauma can generate pathological neural activity that is believed to be responsible for many types of chronic pain and tinnitus. Several studies have reported that the severity of chronic pain and tinnitus is correlated with the degree of map reorganization in somatosensory and auditory cortex, respectively. Direct electrical or transcranial magnetic stimulation of sensory cortex can temporarily disrupt these phantom sensations. However, there is as yet no direct evidence for a causal role of plasticity in the generation of pain or tinnitus. Here we report evidence that reversing the brain changes responsible can eliminate the perceptual impairment in an animal model of noise-induced tinnitus. Exposure to intense noise degrades the frequency tuning of auditory cortex neurons and increases cortical synchronization. Repeatedly pairing tones with brief pulses of vagus nerve stimulation completely eliminated the physiological and behavioural correlates of tinnitus in noise-exposed rats. These improvements persisted for weeks after the end of therapy. This method for restoring neural activity to normal may be applicable to a variety of neurological disorders.
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              Development of the Tinnitus Handicap Inventory.

              To develop a self-report tinnitus handicap measure that is brief, easy to administer and interpret, broad in scope, and psychometrically robust. A standardization study of a self-report tinnitus handicap measure was conducted to determine its internal consistency reliability and convergent and construct validity. Audiology clinics in tertiary care centers in two sites. In the first investigation, 84 patients reporting tinnitus as their primary complaint or secondary to hearing loss completed the 45-item alpha version of the Tinnitus Handicap Inventory (THI). In the second investigation, 66 subjects also reporting tinnitus completed the 25-item beta version. Convergent validity was assessed using another measure of perceived tinnitus handicap (Tinnitus Handicap Questionnaire). Construct validity was assessed using the Beck Depression Inventory, Modified Somatic Perception Questionnaire, symptom rating scales (annoyance, sleep disruption, depression, and concentration), and perceived tinnitus pitch and loudness judgments. From the alpha version of the THI, we derived a 25-item beta version with the items grouped into functional, emotional, and catastrophic subscales. The total scale yielded excellent internal consistency reliability (Cronbach's alpha = .93). No significant age or gender effects were seen. Weak correlations were observed between the THI and the Beck Depression Inventory, Modified Somatic Perception Questionnaire, and pitch and loudness judgments. Significant correlations were found between the THI and the symptom rating scales. The THI is a self-report measure that can be used in a busy clinical practice to quantify the impact of tinnitus on daily living.
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                Author and article information

                Journal
                J Audiol Otol
                J Audiol Otol
                JAO
                Journal of Audiology & Otology
                The Korean Audiological Society
                2384-1621
                2384-1710
                December 2015
                18 December 2015
                : 19
                : 3
                : 159-167
                Affiliations
                Department of Otorhinolaryngology, Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
                Author notes
                Address for correspondence: Hyun Joon Shim, MD, PhD. Department of Otorhinolaryngology, Eulji Medical Center, Eulji University School of Medicine, 68 Hangeulbiseok-ro, Nowon-gu, Seoul 01830, Korea. Tel +82-2-970-8276, Fax +82-2-970-8275, eardoc11@ 123456naver.com
                Article
                10.7874/jao.2015.19.3.159
                4704553
                26771015
                e28a94f8-9d1d-40b3-b66b-c4920028367b
                Copyright © 2015 The Korean Audiological Society

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 12 September 2015
                : 17 November 2015
                : 30 November 2015
                Categories
                Original Article

                vagus nerve stimulation,transcutaneous electrical nerve stimulation,music therapy,tinnitus

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