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.
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机译:目的。初级耳鸣对相当一部分普通人群的生活质量具有严重的负面影响。声学协调的重置神经调节旨在引起耳鸣症状的持久减少。为了测试声学协调的重置神经调节在现实生活中对慢性音调耳鸣的治疗效果,ANM GmbH委托进行了门诊研究“ RESET Real Life”。在这里,我们介绍这项研究的结果。方法。在一项针对200名慢性耳鸣患者的前瞻性,开放标签,非随机,非对照的多中心临床研究中,耳鸣问卷TBF-12和全球临床改善印象量表(CGI-I7)用于研究声学协调复位神经调节的安全性和有效性。 。 189名患者完成了最后12个月的访视,其中11例退学(8例由于与治疗无关的原因; 2例由于耳鸣未改变; 1例由于耳鸣变大)。结果。在真实生活条件下治疗12个月后,声学协调重置神经调节导致TBF-12评分以及CGI-I7的统计学和临床显着下降。没有报道与治疗相关的持续不良事件。结论。现场研究“ RESET Real Life”提供了在预期的,开放标签的,真实的环境中进行声协调重置神经调节的安全性和有效性的证据。
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