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

Hauptmann, Christian and Stroebel, Armin and Williams, Mark and Patel, Nitesh and Wurzer, Hannes and von Stackelberg, Tatjana and Brinkmann, Uwe and Langguth, Berthold and Tass, Peter A. (2015) Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus. BIOMED RESEARCH INTERNATIONAL: 569052. ISSN 2314-6133, 2314-6141

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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.

Item Type: Article
Uncontrolled Keywords: BRAIN-STIMULATION; QUESTIONNAIRE; POWER; CONNECTIVITY; NETWORK; TRAUMA; SCALE;
Subjects: 100 Philosophy & psychology > 150 Psychology
600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Psychiatrie und Psychotherapie
Depositing User: Dr. Gernot Deinzer
Date Deposited: 26 Jul 2019 10:34
Last Modified: 26 Jul 2019 10:34
URI: https://pred.uni-regensburg.de/id/eprint/6171

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