Dale M L, Mancini M, Stevens A, Brumbach B H, Prewitt A, Harker G, Silva-Batista C, Ragothaman A, Folmer R L, Quinn J F, Horak F B
Department of Neurology, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR, USA.
Advanced Imaging Research Center, Oregon Health & Science University, Portland, OR, USA.
Contemp Clin Trials Commun. 2023 Jul 14;35:101165. doi: 10.1016/j.conctc.2023.101165. eCollection 2023 Oct.
Methods for modulating the cerebellum with transcranial magnetic stimulation (TMS) are well established, and preliminary data from our group and others has shown evidence of transient improvements in balance after cerebellar repetitive transcranial magnetic stimulation (rTMS) in progressive suprancuclear palsy (PSP). This study examines extensive posturography measures before and after 10 sessions of cerebellar rTMS and sham TMS in PSP.
Thirty subjects with PSP and postural instability will undergo cerebellar active and sham rTMS in a single-blind, crossover design with a randomized order of a 10-day intervention. Primary outcomes will be changes in sway area and medio-lateral range of sway with eyes open while standing on a stationary force-plate, and safety, tolerability, and blindedness. Secondary outcomes will include posturography and gait analysis with body-worn, triaxial inertial sensors, clinical balance scales and questionnaires, and a bedside test of vestibular function. Exploratory outcomes are changes in functional near infrared spectroscopy (fNIRS) signal over the prefrontal, supplementary motor, and primary motor cortices while standing and walking, and speech samples for future analysis.
The C-STIM crossover intervention study adds a longer duration of stimulation and extensive posturography measures to more finely measure the improvements in balance and exploratory functional near-infrared spectroscopy (fNIRS) over the prefronal, supplementary motor, and primary motor cortices during balance assessments before and after 10 sessions of cerebellar rTMS and 10 sessions of sham cerebellar TMS. This project will improve our understanding of the importance of the cerebellum for control of postural stability in PSP.
经颅磁刺激（TMS）调节小脑的方法已得到充分确立，我们团队及其他团队的初步数据表明，在进行性核上性麻痹（PSP）患者中，小脑重复经颅磁刺激（rTMS）后平衡能力有短暂改善的迹象。本研究在PSP患者中，对10次小脑rTMS和假刺激TMS前后进行了广泛的姿势描记法测量。
30名患有PSP且存在姿势不稳的受试者将在单盲、交叉设计中接受小脑主动rTMS和假刺激rTMS，干预顺序随机，为期10天。主要结局将是在固定测力板上睁眼站立时摆动面积和左右摆动范围的变化，以及安全性、耐受性和盲法。次要结局将包括使用可穿戴式三轴惯性传感器进行的姿势描记法和步态分析、临床平衡量表和问卷，以及床边前庭功能测试。探索性结局是站立和行走时前额叶、辅助运动区和初级运动皮层上的功能性近红外光谱（fNIRS）信号变化，以及用于未来分析的语音样本。
C-STIM交叉干预研究增加了更长的刺激持续时间和广泛的姿势描记法测量，以便更精确地测量在10次小脑rTMS和10次假小脑TMS前后的平衡评估中，前额叶、辅助运动区和初级运动皮层上平衡改善情况以及探索性功能性近红外光谱（fNIRS）。该项目将增进我们对小脑在PSP中控制姿势稳定性重要性的理解。
