Spagnolo Francesca, Fichera Mario, Chieffo Raffaella, Dalla Costa Gloria, Pisa Marco, Volonté Maria Antonietta, Falautano Monica, Zangen Abraham, Comi Giancarlo, Leocani Letizia
Experimental Neurophysiology Unit, Institute of Experimental Neurology - INSPE, Scientific Institute Hospital San Raffaele, Milan, Italy.
San Raffaele Vita-Salute University, Milan, Italy.
Front Neurol. 2021 Feb 18;11:584713. doi: 10.3389/fneur.2020.584713. eCollection 2020.
Pilot open-label application of high-frequency repetitive transcranial magnetic stimulation (rTMS) with H-coil in Parkinson's Disease (PD) have shown promising results. To evaluate safety and efficacy of high-frequency rTMS with H-coil in PD in a double-blind, placebo-controlled, randomized study. Sixty patients with PD were randomized into 3 groups: M1-PFC (real stimulation on primary motor-M1 and pre-frontal cortices-PFC), M1 (real rTMS on M1, sham on PFC), Sham (apparent stimulation). Primary outcome was baseline-normalized percent improvement in UPDRS part III OFF-therapy at the end of treatment (12 rTMS sessions, 4 weeks). Secondary outcomes were improvement in UPDRS part III sub-scores, timed tests, and neuropsychological tests. Statistical analysis compared improvement following real and sham stimulation at the end of the protocol using either a -test or a Mann-Whitney test. All patients tolerated the treatment and concluded the study. One patient from M1-PFC group was excluded from the analysis due to newly discovered uncontrolled diabetes mellitus. No serious adverse effect was recorded. At the end of treatment, patients receiving real rTMS (M1-PFC and M1 combined) showed significantly greater improvement compared to sham in UPDRS part III total score ( = 0.007), tremor subscore ( = 0.011), and lateralized sub-scores ( = 0.042 for the more affected side; = 0.012 for the less affected side). No significant differences have been oserved in safety and efficacy outcomes between the two real rTMS groups. Notably, mild, not-distressing and transient dyskinesias occurred in 3 patients after real rTMS in OFF state. The present findings suggest that high-frequency rTMS with H-coil is a safe and potentially effective procedure and prompt larger studies for validation as add-on treatment in PD.
使用H型线圈进行高频重复经颅磁刺激(rTMS)在帕金森病(PD)中的初步开放标签应用已显示出有前景的结果。在一项双盲、安慰剂对照、随机研究中评估使用H型线圈进行高频rTMS治疗PD的安全性和有效性。60例PD患者被随机分为3组:M1-前额叶皮质组(对初级运动皮质-M1和前额叶皮质-PFC进行真实刺激)、M1组(对M1进行真实rTMS,对PFC进行假刺激)、假刺激组(模拟刺激)。主要结局是治疗结束时(12次rTMS治疗,4周)非治疗状态下统一帕金森病评定量表(UPDRS)第三部分相对于基线的改善百分比。次要结局是UPDRS第三部分各亚评分、计时测试和神经心理学测试的改善情况。统计分析使用t检验或曼-惠特尼检验比较方案结束时真实刺激和假刺激后的改善情况。所有患者均耐受治疗并完成研究。M1-前额叶皮质组的1例患者因新发现的未控制糖尿病被排除在分析之外。未记录到严重不良反应。治疗结束时,接受真实rTMS(M1-前额叶皮质组和Ml组合计)的患者在UPDRS第三部分总分(P = 0.007)、震颤亚评分(P = 0.011)和侧别亚评分(患侧较重者P = 0.042;患侧较轻者P = 0.012)方面与假刺激组相比改善显著更大。两个真实rTMS组在安全性和有效性结局方面未观察到显著差异。值得注意的是,3例患者在真实rTMS治疗后处于非治疗状态时出现了轻度、不令人困扰且短暂的运动障碍。目前的研究结果表明,使用H型线圈进行高频rTMS是一种安全且可能有效的治疗方法,并促使开展更大规模的研究以验证其作为PD附加治疗的效果。