Abramavičius Silvijus, Venslauskas Mantas, Vaitkus Antanas, Gudžiūnas Vaidotas, Laucius Ovidijus, Stankevičius Edgaras
Laboratory of Preclinical Drug Investigation Institute of Cardiology, Lithuanian University of Health Sciences 1, 44307 Kaunas, Lithuania.
Institute of Mechatronics, Kaunas University of Technology, 44249 Kaunas, Lithuania.
Medicina (Kaunas). 2020 Oct 21;56(10):552. doi: 10.3390/medicina56100552.
tremor is an unintentional and rhythmic movement of any part of the body that is a typical symptom of Essential Tremor (ET). ET impairs the quality of life of patients and is treated with pharmacotherapy. We investigated the tremor reduction efficacy of an innovative vibrational medical device (IMD) in ET patients. : we conducted a prospective, single-center, single-arm, pragmatic study in ET patients with an extended safety study to evaluate the efficacy and safety of the Vilim Ball-a local hand-arm vibration device that produces vibrations in the frequency range of 8-18 Hz and amplitude from 0 to 2 mm. The primary endpoint was the decrease in the power spectrum after device use. The secondary endpoints were safety outcomes. In total, 17 patients with ET were included in the main study, and no patients withdrew from the main study. The tremor power spectrum (m/s Hz) was lower after the device use, represented as the mean (standard deviation): 0.106 (0.221); median (Md) 0.009 with the interquartile range; IQR, 0.087 vs. 0.042 (0.078); Md = 0.009 with the IQR 0.012; Wilcoxon signed-rank test V = 123; and = 0.027. Seven patients reported that vibrational therapy was not effective. Two patients reported an increase in tremor after using the device. In the extended safety study, we included 51 patients: 31 patients with ET and 20 with Parkinsonian tremor, where 48 patients reported an improvement in tremor symptoms and 49 in function. No serious adverse events were reported, while two patients in the Parkinsonian tremor group reported a lack of efficacy of the proposed medical device. the device reduces essential tremor in some patients and is safe to use in ET.
震颤是身体任何部位的一种无意识的有节奏运动，是特发性震颤（ET）的典型症状。ET会损害患者的生活质量，通常采用药物治疗。我们研究了一种创新的振动医疗设备（IMD）对ET患者震颤减轻的疗效。我们对ET患者进行了一项前瞻性、单中心、单臂、实用性研究，并进行了扩展安全性研究，以评估Vilim Ball（一种局部手臂振动设备，其产生的振动频率范围为8 - 18Hz，振幅为0至2mm）的疗效和安全性。主要终点是使用设备后功率谱的降低。次要终点是安全性结果。总共有17名ET患者纳入主要研究，且无患者退出主要研究。使用设备后震颤功率谱（m/s²Hz）降低，其均值（标准差）为：0.106（0.221）；中位数（Md）为0.009，四分位间距（IQR）为0.087，而使用前为0.042（0.078）；Md = 0.009，IQR为0.012；Wilcoxon符号秩检验V = 123，P = 0.027。7名患者报告振动疗法无效。2名患者报告使用设备后震颤增加。在扩展安全性研究中，我们纳入了51名患者：31名ET患者和20名帕金森震颤患者，其中48名患者报告震颤症状有所改善，49名患者报告功能有所改善。未报告严重不良事件，而帕金森震颤组有2名患者报告所提议的医疗设备无效。该设备可减轻部分患者的特发性震颤，且在ET患者中使用是安全的。
