CVS Health Clinical Trial Services LLC, Woonsocket, RI, USA.
Cala Health, Inc., San Mateo, CA, USA.
Tremor Other Hyperkinet Mov (N Y). 2023 Oct 16;13:38. doi: 10.5334/tohm.798. eCollection 2023.
Transcutaneous afferent patterned stimulation (TAPS) is a wrist-worn, non-invasive therapy delivering calibrated stimulation to the median and radial nerves. Previous randomized controlled studies have demonstrated the efficacy and safety of TAPS therapy in some patients with essential tremor (ET), but evidence supporting therapeutic benefits of TAPS versus standard of care (SOC) is lacking. This randomized prospective study evaluated the clinical benefit of adding TAPS treatment to SOC versus SOC alone.
This randomized pragmatic trial recruited patients from a large health plan's Commercially Insured and Medicare Advantage population. All 310 patients received a TAPS device and were randomized 1:1 to either one month adding TAPS therapy to usual care (TX arm) or usual care with tremor assessment only (SOC arm). The pre-specified endpoints were changes in tremor power measured by motion sensors on the device (primary) and improvement in Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores (secondary) between TX and SOC in all patients who completed the one-month study.
276 patients completed the one-month study (N = 133 TX, N = 143 SOC). The study met the primary and secondary endpoints, with significantly reduced tremor power in TX compared with SOC (0.017 (0.003) versus 0.08 (0.014) (m/s); geometric mean (SE); < 0.0001) and greater improvement in the BF-ADL score in TX than SOC (1.6 (0.43) vs 0.2 (0.37) points; mean (SE); < 0.05). No serious device-related adverse events were reported.
This trial demonstrates that adding TAPS treatment to SOC significantly improves tremor power and BF-ADLs in patients with ET compared to SOC alone over one month of home use.
This study found that adding TAPS treatment to SOC significantly improves tremor power and BF-ADL scores in patients with ET compared to SOC alone over one month of home use. This real-world evidence study suggests that non-invasive TAPS therapy is a safe and valuable treatment option for patients with ET.
经皮传入模式刺激（TAPS）是一种腕戴式、非侵入性疗法，可向正中神经和桡神经提供校准刺激。先前的随机对照研究已经证明了 TAPS 疗法在一些特发性震颤（ET）患者中的疗效和安全性，但缺乏 TAPS 治疗相对于标准治疗（SOC）的治疗益处的证据。这项随机前瞻性研究评估了在 SOC 中添加 TAPS 治疗与仅 SOC 相比的临床益处。
这项随机实用试验从一个大型健康计划的商业保险和医疗保险优势人群中招募了患者。所有 310 名患者都接受了 TAPS 设备，并按 1:1 随机分为 SOC 组（SOC 臂）和在 SOC 基础上添加一个月 TAPS 治疗的 TX 组（TX 臂）。主要终点是通过设备上的运动传感器测量的震颤功率变化（主要终点）和 Bain & Findley 日常生活活动（BF-ADL）上肢评分的改善（次要终点），所有完成一个月研究的患者在 TX 和 SOC 之间。
276 名患者完成了一个月的研究（N = 133 TX，N = 143 SOC）。该研究达到了主要和次要终点，与 SOC 相比，TX 组的震颤功率显著降低（0.017（0.003）对 0.08（0.014）（m/s）；几何平均值（SE）；<0.0001），TX 组的 BF-ADL 评分改善更大（1.6（0.43）对 0.2（0.37）点；平均值（SE）；<0.05）。未报告严重的设备相关不良事件。
这项试验表明，与 SOC 相比，在 SOC 基础上添加 TAPS 治疗在一个月的家庭使用中可显著改善 ET 患者的震颤功率和 BF-ADLs。
这项研究发现，与 SOC 相比，在一个月的家庭使用中，在 SOC 基础上添加 TAPS 治疗可显著改善 ET 患者的震颤功率和 BF-ADL 评分。这项真实世界证据研究表明，非侵入性 TAPS 治疗是 ET 患者的一种安全且有价值的治疗选择。
