Erratum: TREMOR12: An Open-Source Mobile App for Tremor Quantification

Background: Evaluating the effect of treatment of tremor is mostly performed with clinical rating scales. Mobile applications facilitate a more rapid, objective, and quantitative evaluation of treatment effect. Existing mobile apps do not offer raw data access, which limits algorithm development. Objective: To develop a novel open-source mobile app for tremor quantification. Methods: TREMOR12 is an open-source mobile app that samples acceleration, rotation, rotation speed, and gravity, each in 3 axes and time-stamped in a frequency up to 100 Hz. The raw measurement data can be exported as a comma-separated value file for further analysis in the TREMOR12P data processing module. The app was evaluated with 3 patients suffering from essential tremor, who were between 55 and 71 years of age. Results: This proof-of-concept study shows that the TREMOR12 app is able to detect and register tremor characteristics such as acceleration, rotation, rotation speed, and gravity in a simple and nonburdensome way. The app is compatible with current regulatory oversight by the European Union (MEDDEV regulations) and the Food and Drug Administration (FDA) guidance on mobile medical applications. Conclusion: TREMOR12 offers low-cost tremor quantification for research purposes and algorithm development, and may help to improve treatment evaluation.背景：震颤治疗效果的评估目前多采用临床评定量表完成。移动应用程序可实现更快速、客观且定量的治疗效果评估，但现有移动应用均未开放原始数据访问权限，这限制了相关算法的研发。 研究目的：开发一款用于震颤量化的新型开源移动应用程序。 方法：TREMOR12是一款开源移动应用，可采集3轴方向的加速度、旋转角度、旋转速度及重力数据，采样频率最高可达100 Hz且所有数据均附带时间戳。其原始测量数据可导出为逗号分隔值（comma-separated value，CSV）文件，供TREMOR12P数据处理模块开展进一步分析。本研究纳入3名年龄介于55~71岁的特发性震颤（essential tremor）患者对该应用开展评估。 结果：本概念验证研究结果显示，TREMOR12应用可通过简便且无负担的方式，检测并记录震颤相关特征，如加速度、旋转角度、旋转速度及重力数据。该应用符合欧盟医疗设备（MEDDEV）法规及美国食品药品监督管理局（Food and Drug Administration, FDA）移动医疗应用的现行监管指南。 结论：TREMOR12可为科研与算法研发提供低成本的震颤量化方案，或有助于改善震颤治疗效果的评估工作。