Parkinson's Disease and Movement Disorders of Boca Raton, Boca Raton, FL, USA.
Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.
Expert Rev Med Devices. 2023 Jul-Dec;20(12):1211-1218. doi: 10.1080/17434440.2023.2274604. Epub 2023 Nov 24.
Transcutaneous afferent patterned stimulation (TAPS) is a noninvasive neuromodulation therapy that improves hand tremor in essential tremor (ET) patients. The benefits of TAPS in ET patients with high unmet need (severe tremor, non-responsive to medication, age ≥65 years) and early responders (substantial TAPS tremor improvement in the first month) remains unknown.
Literature was surveyed for TAPS studies to assess the response in the high unmet need subgroup and early responders. Analyses were performed using previously collected Tremor Research Group Essential Tremor Rating Scale (TETRAS) scores, Bain & Findley activities of daily living (BF-ADL) scores, and tremor power.
Significant differences in BF-ADL and TETRAS improvement were observed with TAPS over sham for the high unmet need subgroup in a randomized controlled study (<0.03). During a 3-month open-label study, the high unmet need subgroup and early responders showed significant improvements in BF-ADL, TETRAS, and tremor power (<0.001). Analysis of previous real-world evidence demonstrated that early responders maintained effectiveness and usage at 3 and 12 months (<0.001).
TAPS showed comparable improvements in ET with high unmet need as reported in the original studies, and greater efficacy in early responders. These findings inform patient selection and the trial process for identifying TAPS responders.
经皮传入模式刺激（TAPS）是一种非侵入性神经调节疗法，可改善特发性震颤（ET）患者的手部震颤。TAPS 对高未满足需求（震颤严重、对药物无反应、年龄≥65 岁）和早期应答者（第一个月 TAPS 震颤显著改善）的 ET 患者的益处尚不清楚。
对 TAPS 研究进行文献检索，以评估高未满足需求亚组和早期应答者的反应。使用先前收集的震颤研究小组特发性震颤评定量表（TETRAS）评分、贝恩和芬德利日常生活活动量表（BF-ADL）评分和震颤功率进行分析。
一项随机对照研究显示，与假刺激相比，TAPS 在高未满足需求亚组中对 BF-ADL 和 TETRAS 改善具有显著差异（<0.03）。在为期 3 个月的开放标签研究中，高未满足需求亚组和早期应答者在 BF-ADL、TETRAS 和震颤功率方面均显示出显著改善（<0.001）。对先前真实世界证据的分析表明，早期应答者在 3 个月和 12 个月时保持了有效性和使用率（<0.001）。
TAPS 在高未满足需求的 ET 中显示出与原始研究报告相似的改善效果，并且在早期应答者中更有效。这些发现为 TAPS 应答者的患者选择和试验过程提供了信息。
