Table_1_Transcutaneous Afferent Patterned Stimulation Therapy Reduces Hand Tremor for One Hour in Essential Tremor Patients.XLSX

Essential tremor (ET) patients often experience hand tremor that impairs daily activities. Non-invasive electrical stimulation of median and radial nerves in the wrist using a recently developed therapy called transcutaneous afferent patterned stimulation (TAPS) has been shown to provide symptomatic tremor relief in ET patients and improve patients’ ability to perform functional tasks, but the duration of tremor reduction is unknown. In this single-arm, open-label study, fifteen ET patients performed four hand tremor-specific tasks (postural hold, spiral drawing, finger-to-nose reach, and pouring) from the Fahn-Tolosa-Marin Clinical Rating Scale (FTM-CRS) prior to, during, and 0, 30, and 60 min following TAPS. At each time point, tremor severity was visually rated according to the FTM-CRS and simultaneously measured by wrist-worn accelerometers. The duration of tremor reduction was assessed using (1) improvement in the mean FTM-CRS score across all four tasks relative to baseline, and (2) reduction in accelerometer-measured tremor power relative to baseline for each task. Patients were labeled as having at least 60 min of therapeutic benefit from TAPS with respect to each specified metric if all three (i.e., 0, 30, and 60 min) post-therapy measurements were better than that metric’s baseline value. The mean FTM-CRS scores improved for at least 60 min beyond the end of TAPS for 80% (12 of 15, p = 4.6e–9) of patients. Similarly, for each assessed task, tremor power improved for at least 60 min beyond the end of TAPS for over 70% of patients. The postural hold task had the largest reduction in tremor power (median 5.9-fold peak reduction in tremor power) and had at least 60 min of improvement relative to baseline beyond the end of TAPS therapy for 73% (11 of 15, p = 9.8e–8) of patients. Clinical ratings of tremor severity were correlated to simultaneously recorded accelerometer-measured tremor power (r = 0.33–0.76 across the four tasks), suggesting tremor power is a valid, objective tremor assessment metric that can be used to track tremor symptoms outside the clinic. These results suggest TAPS can provide reductions in upper limb tremor symptoms for at least 1 h post-therapy in some patients, which may improve patients’ ability to perform tasks of daily living.

原发性震颤（Essential Tremor, ET）患者常出现手部震颤，该症状会损害其日常活动能力。采用新近开发的经皮传入模式刺激（Transcutaneous Afferent Patterned Stimulation, TAPS）疗法，对腕部正中神经与桡神经进行无创电刺激，已被证实可缓解原发性震颤患者的震颤症状，并提升患者完成功能性任务的能力，但目前尚不明确震颤缓解的持续时长。本项单臂开放标签临床试验中，15名原发性震颤患者分别在TAPS治疗前、治疗期间，以及治疗结束后0、30、60分钟，完成了源自Fahn-Tolosa-Marin临床评定量表（Fahn-Tolosa-Marin Clinical Rating Scale, FTM-CRS）的4项手部震颤特异性任务：姿势保持、螺旋绘图、指鼻触碰与倒水操作。在每个时间节点，研究人员均依据FTM-CRS对震颤严重程度进行人工目视评分，同时通过腕部佩戴式加速度计同步测量震颤情况。本研究通过两项指标评估震颤缓解的持续时长：（1）相较于基线水平，4项任务的平均FTM-CRS评分改善情况；（2）相较于基线水平，各任务中加速度计测得的震颤功率降低幅度。若患者在治疗后三个时间点（即0、30、60分钟）的各项指定指标测量值均优于该指标的基线水平，则判定其经TAPS治疗后获得了至少60分钟的临床获益。80%的患者（15例中12例，p=4.6×10^-9）的平均FTM-CRS评分在TAPS治疗结束后，至少维持了60分钟的改善状态。同样，在各项被评估的任务中，超过70%的患者其震颤功率在TAPS治疗结束后，至少维持了60分钟的改善状态。姿势保持任务的震颤功率降低幅度最大（震颤功率峰值中位数降低5.9倍），且73%的患者（15例中11例，p=9.8×10^-8）在该任务中的评分在TAPS治疗结束后，相较于基线水平至少维持了60分钟的改善状态。震颤严重程度的临床评分与加速度计同步测得的震颤功率呈显著相关（4项任务的相关系数r介于0.33~0.76之间），这表明震颤功率是一项可靠、客观的震颤评估指标，可用于在临床场景外追踪震颤症状。上述结果表明，部分原发性震颤患者在接受TAPS治疗后，上肢震颤症状可在治疗结束后至少持续1小时的缓解状态，这或有助于提升患者完成日常活动任务的能力。