Clinical benefit of transcutaneous afferent patterned stimulation (TAPS) in essential tremor patients with high unmet need: a secondary analysis of TAPS studies.

Expert review of medical devices Pub Date : 2023-07-01 Epub Date: 2023-11-24 DOI:10.1080/17434440.2023.2274604
Stuart H Isaacson, Rajesh Pahwa, Salima Brillman, Chiahao Lu, Alexander R Kent
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Abstract

Background: 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.

Research design and methods: 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.

Results: 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 (P<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 (P<0.001). Analysis of previous real-world evidence demonstrated that early responders maintained effectiveness and usage at 3 and 12 months (P<0.001).

Conclusions: 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.

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经皮传入模式刺激对高未满足需求的特发性震颤患者的临床益处:对TAPS研究的二次分析
背景:经皮传入模式刺激(TAPS)是一种无创的神经调控疗法,可改善原发性震颤(ET)患者的手震颤。TAPS对有高度未满足需求(严重震颤、对药物无反应、年龄≥65岁)的ET患者的益处 年)和早期反应者(第一个月TAPS震颤的显著改善和使用)仍然未知。研究设计和方法:对TAPS研究的文献进行调查,以评估高未满足需求亚组和早期反应队列的临床反应。使用先前收集的震颤研究组基本震颤评定量表(TETRAS)评分、Bain&Findley日常生活活动量表(BF-ADL)评分和震颤力测量对这些患者进行二次分析。结果:在一项随机对照研究中,对于高未满足需求亚组,TAPS与假手术相比,在BF-ADL和TETRAS改善方面存在显著差异(N = 47,P N = 138)和早期反应者队列(N = 51)表现出BF-ADL、TETRAS和震颤能力的显著改善(P N = 191,P N = 76,P 结论:TAPS在ET方面表现出相当的改善,如原始研究中报道的那样,有较高的未满足需求,并且在早期反应者中有更大的疗效。这些发现为患者选择和确定TAPS应答者的试验过程提供了信息。
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