通过皮肤对基本震进行感应模式刺激:现实世界的证据与长期随访
Chiahao Lu1, Dhira Khosla1, Alexander Kent1
1Cala Health Inc, San Mateo, CA, USA.
Tremor and other hyperkinetic movements (New York, N.Y.)
|September 4, 2023
概括
在一项大型现实世界的研究中,通过皮肤进行 afferent 模式刺激 (TAPS) 有效地减少了基本震 (ET). 这种非侵入性治疗显示了持续的益处和超过90天的良好的安全性.
科学领域:
- 神经学 神经学
- 生物医学工程 生物医学工程
背景情况:
- 基本震 (ET) 是一种神经障碍,导致非自愿的手.
- 穿皮 afferent 模式刺激 (TAPS) 是用于ET管理的非侵入性神经调节疗法.
研究的目的:
- 为了评估TAPS在ET患者的实际使用,有效性和安全性,超过最初的90天试验期.
- 评估TAPS治疗的长期结果和患者报告的益处.
主要方法:
- 对制造商对用于ET的TAPS设备数据库的回顾性分析.
- 纳入标准:在2019年8月至2023年1月期间,TAPS使用超过90天.
- 收集的数据:设备日志 (使用情况,加速度计,车载评级) 和自愿的试验后调查. 从患者的投诉中评估了不良事件.
主要成果:
- 1,223名患者符合标准,使用TAPS90-1,233天 (平均时间为90-1,233天). 5.6个会议/周).
- 加速度计显示,89%的患者有震的改善 (平均值). 64%) 的比例. 63%的受访者报告说,他们的会话有所改善.
- 一年后没有观察到任何显著的习惯. 62%的受访者考虑减少使用药物. 10%的患者有轻微的安全投诉;没有严重事件.
结论:
- 在90天以后,TAPS证明了对必要的震管理的实际有效性和安全性.
- 该疗法在大量患者群体中提供了持续的震减缓和积极的安全概况.
- TAPS可能提供一种可行的替代品或辅助ET的药物治疗.
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