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

Hyun Joon Shim, Min Young Kwak, Yong-Hwi An, Dong Hyun Kim, Yun Jin Kim, Hyo Jung Kim, Hyun Joon Shim, Min Young Kwak, Yong-Hwi An, Dong Hyun Kim, Yun Jin Kim, Hyo Jung Kim

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.

Keywords: Music therapy; Tinnitus; Transcutaneous electrical nerve stimulation; Vagus nerve stimulation.

Figures

Fig. 1. Global improvement (GI) index and…
Fig. 1. Global improvement (GI) index and change in Visual Analogue Scale (VAS) of tinnitus loudness (10-point), tinnitus awareness score (TAS, %), and Tinnitus Handicap Inventory (THI) score immediately after the end of the 10th session. Of the 30 patients, 15 patients reported an improvement in symptom (grade 5 and 6), 13 patients reported no change (grade 4), and 2 patients reported mild worsening of symptoms (grade 3). In 16/25 patients (64.0%), the VAS of tinnitus loudness decreased (i.e., improved), five patients (20.0%) reported no change in subjective loudness and 4 patients (16.0%) reported an increase in loudness. The tinnitus awareness score decreased (i.e., improved) in 13/25 patients (52.0%), was unchanged in 8/25 patients (32.0%), and increased in 4/25 patients (16.0%). The THI score decreased from baseline to after treatment in 11/24 patients (45.8%), was unchanged in 3 patients (12.5%), and worsened in 10 patients (41.7%).
Fig. 2. Time to symptom relief was…
Fig. 2. Time to symptom relief was not significantly correlated with the improvement (post score-pre score) in Visual Analogue Scale (VAS) of the tinnitus loudness, tinnitus awareness score (TAS), and Tinnitus Handicap Inventory (THI), or with the global improvement (GI) index in the 15 patients who reported improvements in their symptoms (all p>0.05).

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