Feasibility, Safety and Efficacy of Transcutaneous Vagus Nerve Stimulation in Chronic Tinnitus: An Open Pilot Study

Brain Stimulation

卷:7

Michael Landgrebe¹  Markus Resch²  Martin Schecklmann³  Florian Geisreiter³  Berthold Langguth⁴  Peter M. Kreuzer⁴  Timm B. Poeppl⁴  Sarah J. Prasser⁴  Rainer Rupprecht⁴  Goeran Hajak⁴  Oliver Husser⁵ 

[1] Corresponding author. Tel.: [phone];

[2] fax: [phone].;

[3] Department of Cardiology, Internal Medicine II, University of Regensburg, Regensburg, Germany;

[4] Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany;

[5] Department of Psychiatry, Psychosomatics and Psychotherapy, kbo Lech-Mangfall-Klinik Agatharied, Germany;

关键词: Transcutaneous vagus nerve stimulation;    Neuromodulation;    Chronic tinnitus;   

DOI  :  

来源: DOAJ

【 摘 要 】

Objectives: Vagus nerve stimulation represents an established treatment strategy for epilepsy and affective disorders. Recently, positive effects were also shown in animals and humans with tinnitus. Here we report the results of an open pilot study exploring feasibility, safety and efficacy of tVNS in the treatment of chronic tinnitus. Study design: Fifty patients with chronic tinnitus underwent tVNS in an open single-armed pilot study which was conducted in two phases applying two different stimulating devices (Cerbomed CM02 and NEMOS). Clinical assessment was based on Tinnitus Questionnaire (TQ), Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), WHO Quality of Life, and various numeric rating scales. Primary outcome was defined as change in TQ (baseline vs. final visit in week 24). The study has been registered with clinicaltrials.gov (NCT01176734). Results: Primary analysis indicated mean TQ reductions of 3.7 points (phase 1) and 2.8 points (phase 2) significant for the first study phase. Secondary analyses indicated a significant BDI reduction for phase 1 (uncorrected for multiple testing), but no further systematic or significant effects. Adverse events included twitching and pressure at electrode placement site. The occurrence of one hospitalization because of palpations and the development of a left bundle branch block were considered as unrelated to the intervention. Cognitive testing revealed no significant changes. Conclusion: Our data demonstrate the feasibility of tVNS over a period of 6 months. There was no clinically relevant improvement of tinnitus complaints. Our data suggest tVNS to be considered safe in patients without a history of cardiac disease.

【 授权许可】

Unknown