Lench Daniel H, Turner Travis H, McLeod Colin, Boger Heather A, Lovera Lilia, Heidelberg Lisa, Elm Jordan, Phan Anh, Badran Bashar W, Hinson Vanessa K
Department of Neurology, Medical University of South Carolina, Charleston, SC, United States.
Department of Neurology, Augusta University Medical Center, Augusta, GA, United States.
Front Neurol. 2023 Jul 18;14:1210103. doi: 10.3389/fneur.2023.1210103. eCollection 2023.
In pre-clinical animal models of Parkinson's disease (PD), vagus nerve stimulation (VNS) can rescue motor deficits and protect susceptible neuronal populations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a non-invasive alternative to traditional invasive cervical VNS. This is the first report summarizing the safety, feasibility, and preliminary efficacy of repeated sessions of taVNS in participants with PD.
To evaluate the feasibility, safety, and possible efficacy of taVNS for motor and non-motor symptoms in mild to moderate PD.
This is a double-blind, sham controlled RCT (NCT04157621) of taVNS in 30 subjects with mild to moderate PD without cognitive impairment. Participants received 10, 1-h taVNS sessions (25 Hz, 200% of sensory threshold, 500 μs pulse width, 60 s on and 30 s off) over a 2-week period. Primary outcome measures were feasibility and safety of the intervention; secondary outcomes included the MDS-UPDRS, cognitive function and self-reported symptom improvement.
taVNS treatment was feasible, however, daily in-office visits were reported as being burdensome for participants. While five participants in the taVNS group and three in the sham group self-reported one or more minor adverse events, no major adverse events occurred. There were no group differences on blood pressure and heart rate throughout the intervention. There were no group differences in MDS-UPDRS scores or self-reported measures. Although global cognitive scores remained stable across groups, there was a reduction in verbal fluency within the taVNS group.
taVNS was safe, and well-tolerated in PD participants. Future studies of taVNS for PD should explore at-home stimulation devices and optimize stimulation parameters to reduce variability and maximize engagement of neural targets.
在帕金森病（PD）的临床前动物模型中，迷走神经刺激（VNS）可挽救运动功能障碍并保护易感神经元群体。经皮耳迷走神经刺激（taVNS）已成为传统侵入性颈迷走神经刺激的非侵入性替代方法。这是第一份总结taVNS在PD患者中重复治疗的安全性、可行性和初步疗效的报告。
评估taVNS对轻度至中度PD患者运动和非运动症状的可行性、安全性及可能的疗效。
这是一项双盲、假刺激对照的随机对照试验（NCT04157621），纳入30例无认知障碍的轻度至中度PD患者。参与者在2周内接受10次，每次1小时的taVNS治疗（25Hz，感觉阈值的200%，500μs脉冲宽度，开60秒，关30秒）。主要结局指标为干预的可行性和安全性；次要结局包括MDS-UPDRS、认知功能和自我报告的症状改善。
taVNS治疗是可行的，然而，参与者报告每日到办公室就诊很麻烦。taVNS组有5名参与者，假刺激组有3名参与者自我报告了1种或更多种轻微不良事件，但未发生重大不良事件。在整个干预过程中，两组的血压和心率无差异。MDS-UPDRS评分或自我报告指标在两组间无差异。尽管各组的整体认知评分保持稳定，但taVNS组的语言流畅性有所下降。
taVNS在PD患者中是安全且耐受性良好的。未来关于taVNS治疗PD的研究应探索家用刺激设备并优化刺激参数，以减少变异性并最大化神经靶点的参与度。
