title: Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany. Electronic address: peter.kreuzer@medbo.de.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Kreuzer
authors.affiliation: Department of Psychiatry, Psychosomatics and Psychotherapy, kbo Lech-Mangfall-Klinik Agatharied, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Landgrebe
authors.affiliation: Department of Cardiology, Internal Medicine II, University of Regensburg, Regensburg, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Resch
authors.affiliation: Department of Cardiology, Internal Medicine II, University of Regensburg, Regensburg, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Husser
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Schecklmann
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Geisreiter
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany.
authors.forename: Timm B
authors.initials: TB
authors.lastname: Poeppl
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany.
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Prasser
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, Bezirksklinikum Bamberg, Bamberg, Germany.
authors.forename: Goeran
authors.initials: G
authors.lastname: Hajak
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany.
authors.forename: Rainer
authors.initials: R
authors.lastname: Rupprecht
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstr. 84, 93053 Regensburg, Germany.
authors.forename: Berthold
authors.initials: B
authors.lastname: Langguth
mesh_terms: D000328:Adult; D000368:Aged; D002908:Chronic Disease; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012449:Safety; D011795:Surveys and Questionnaires; D014012:Tinnitus / Q000175:diagnosis* / Q000628:therapy*; D004561:Transcutaneous Electric Nerve Stimulation / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000009:adverse effects / Q000379:methods*
keywords: Chronic tinnitus; Neuromodulation; Transcutaneous vagus nerve stimulation