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BioMed Research International
Volume 2015, Article ID 569052, 8 pages
http://dx.doi.org/10.1155/2015/569052
Clinical Study

Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus

1Institute of Neuroscience and Medicine-Neuromodulation (INM-7), Jülich Research Center, 52425 Jülich, Germany
2CERES GmbH Evaluation & Research, 79539 Lörrach, Germany
3The Tinnitus Clinic Inc., London W1G 6AX, UK
4Tinnitus Zentrum Promenadeplatz, 80333 München, Germany
5Ear, Nose and Throat (ENT) Center, 40667 Meerbusch, Germany
6Ear, Nose and Throat (ENT) Clinic Hamm-Ahlen-Oelde, 59302 Oelde, Germany
7Department of Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany
8Department of Neurosurgery, Stanford University, Stanford, CA 94305, USA
9Department of Neuromodulation, University of Cologne, 50923 Cologne, Germany

Received 3 November 2014; Accepted 11 January 2015

Academic Editor: Aage R. Møller

Copyright © 2015 Christian Hauptmann et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Purpose. Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study “RESET Real Life” was commissioned by ANM GmbH. Herein we present the results of this study. Methods. In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder). Results. Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy. Conclusion. The field study “RESET Real Life” provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting.