Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.

Abstract

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.

• Authors: Peter M Kreuzer, Michael Landgrebe, Markus Resch, Oliver Husser, Martin Schecklmann, Florian Geisreiter, Timm B Poeppl, Sarah J Prasser, Goeran Hajak, Rainer Rupprecht, Berthold Langguth
• Journal: Brain stimulation (Brain Stimul) 2014 Sep-Oct Vol. 7 Issue 5 Pg. 740-7 ISSN: 1876-4754 [Electronic] United States
• PMID: 24996510 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier Inc. All rights reserved.

Topics

• Adult
• Aged
• Chronic Disease
• Female
• Humans
• Male
• Middle Aged
• Pilot Projects
• Psychiatric Status Rating Scales
• Quality of Life
• Safety
• Surveys and Questionnaires
• Tinnitus (diagnosis, therapy)
• Transcutaneous Electric Nerve Stimulation (adverse effects, methods)
• Treatment Outcome
• Vagus Nerve Stimulation (adverse effects, methods)