title: Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute of Neuroscience and Medicine-Neuromodulation (INM-7), Jülich Research Center, 52425 Jülich, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Hauptmann
authors.affiliation: CERES GmbH Evaluation & Research, 79539 Lörrach, Germany.
authors.forename: Armin
authors.initials: A
authors.lastname: Ströbel
authors.affiliation: The Tinnitus Clinic Inc., London W1G 6AX, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Williams
authors.affiliation: The Tinnitus Clinic Inc., London W1G 6AX, UK.
authors.forename: Nitesh
authors.initials: N
authors.lastname: Patel
authors.affiliation: Tinnitus Zentrum Promenadeplatz, 80333 München, Germany.
authors.forename: Hannes
authors.initials: H
authors.lastname: Wurzer
authors.affiliation: Ear, Nose and Throat (ENT) Center, 40667 Meerbusch, Germany.
authors.forename: Tatjana
authors.initials: T
authors.lastname: von Stackelberg
authors.affiliation: Ear, Nose and Throat (ENT) Clinic Hamm-Ahlen-Oelde, 59302 Oelde, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Brinkmann
authors.affiliation: Department of Psychiatry and Psychotherapy, University of Regensburg, 93053 Regensburg, Germany.
authors.forename: Berthold
authors.initials: B
authors.lastname: Langguth
authors.affiliation: Institute of Neuroscience and Medicine-Neuromodulation (INM-7), Jülich Research Center, 52425 Jülich, Germany ; Department of Neurosurgery, Stanford University, Stanford, CA 94305, USA ; Department of Neuromodulation, University of Cologne, 50923 Cologne, Germany.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Tass
mesh_terms: D000161:Acoustic Stimulation / Q000379:methods*; D002908:Chronic Disease; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D014012:Tinnitus / Q000175:diagnosis* / Q000628:therapy*; D016896:Treatment Outcome