TY  - JOUR
AU  - Hauptmann, Christian
AU  - Ströbel, Armin
AU  - Williams, Mark
AU  - Patel, Nitesh
AU  - Wurzer, Hannes
AU  - von Stackelberg, Tatjana
AU  - Brinkmann, Uwe
AU  - Langguth, Berthold
AU  - Tass, Peter A.
TI  - Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus
JO  - BioMed research international
VL  - 2015
SN  - 2314-6141
CY  - New York [u.a.]
PB  - Hindawi
M1  - FZJ-2016-01365
SP  - 569052
PY  - 2015
AB  - 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.
LB  - PUB:(DE-HGF)16
UR  - <Go to ISI:>//WOS:000364067900001
C6  - pmid:26568958
DO  - DOI:10.1155/2015/569052
UR  - https://juser.fz-juelich.de/record/281677
ER  -