■小脑共济失调(CA)是一种运动障碍,可以影响平衡和步态,肢体运动,眼球运动控制,和认知。多系统萎缩-小脑型(MSA-C)和脊髓小脑共济失调3型(SCA3)是最常见的CA形式,目前尚无有效的治疗方法。经颅交流电刺激(tACS)是一种非侵入性的脑刺激方法,旨在改变皮质兴奋性和脑电活动,调节大脑内的功能连接。小脑tACS可以调节小脑流出和小脑相关行为,对人类来说是一种安全的技术。因此,这项研究的目的是1)检查小脑tACS是否改善了由MSA-C和SCA3组成的CA患者的同质队列中的共济失调严重程度和各种非运动症状,2)探索这些影响的时间过程,和3)评估所有参与者的小脑tACS的安全性和耐受性。
■这是一个2周,三盲,随机化,假对照研究。164名患者(MSA-C:84,SCA3:80)将被招募并随机分配到活跃的小脑tACS或假小脑tACS,以1:1的比例。患者,调查员,和结果评估不知道治疗分配。小脑tACS(40分钟,2mA,每个10秒的上升和下降周期)将在10个疗程中交付,分两组,连续五天,中间休息两天。在第10次刺激(T1)后评估结果,1个月(T2)和3个月(T3)后。主要结果指标是在治疗2周后,在共济失调评估和评级量表(SARA)评分中改善1.5分的患者比例中,活跃组和假手术组之间的差异。此外,对各种非运动症状的影响,生活质量,和自主神经功能障碍通过相对尺度评估。步态失衡,构音障碍,手指灵巧是通过相对工具客观评价的。最后,进行功能磁共振成像以探索治疗效果的可能机制。
■这项研究的结果将告知活动性小脑tACS的重复治疗是否有益于CA患者,以及这种形式的非侵入性刺激是否可能是一种在神经康复环境中考虑的新型治疗方法。临床试验注册:ClinicalTrials.gov,标识符NCT05557786;https://www.clinicaltrials.gov/ct2/show/NCT05557786.
UNASSIGNED: Cerebellar ataxia (CA) is a movement disorder that can affect balance and gait, limb movement, oculomotor control, and cognition. Multiple system atrophy-cerebellar type (MSA-C) and spinocerebellar ataxia type 3 (SCA3) are the most common forms of CA, for which no effective treatment is currently available. Transcranial alternating current stimulation (tACS) is a non-invasive method of brain stimulation supposed to alter cortical excitability and brain electrical activity, modulating functional connectivity within the brain. The cerebellar tACS can modulate the cerebellar outflow and cerebellum-linked behavior and it is a proven safe technique for humans. Therefore, the aim of this
study is to 1) examine whether cerebellar tACS improves ataxia severity and various non-motor symptoms in a homogeneous cohort of CA patients consisting of MSA-C and SCA3, 2) explore the time course of these effects, and 3) assess the safety and tolerance of cerebellar tACS in all participants.
UNASSIGNED: This is a 2-week, triple-blind, randomised, sham-controlled
study. 164 patients (MSA-C: 84, SCA3: 80) will be recruited and randomly assigned to either active cerebellar tACS or sham cerebellar tACS, in a 1:1 ratio. Patients, investigators, and outcome assessors are unaware of treatment allocation. Cerebellar tACS (40 min, 2 mA, ramp-up and down periods of 10s each) will be delivered over 10 sessions, distributed in two groups of five consecutive days with a two-day break in between. Outcomes are assessed after the tenth stimulation (T1), and after 1 month (T2) and 3 months (T3). The primary outcome measure is the difference between the active and sham groups in the proportion of patients with an improvement of 1.5 points in the Scale for the Assessment and Rating of Ataxia (SARA) score after 2 weeks of treatment. In addition, effects on a variety of non-motor symptoms, quality of life, and autonomic nerve dysfunctions are assessed via relative scales. Gait imbalance, dysarthria, and finger dexterity are objectively valued via relative tools. Finally, functional magnetic resonance imaging is performed to explore the possible mechanism of treatment effects.
UNASSIGNED: The results of this
study will inform whether repeated sessions of active cerebellar tACS benefit CA patients and whether this form of non-invasive stimulation might be a novel therapeutic approach to consider in a neuro-rehabilitation setting.Clinical
Trial Registration: ClinicalTrials.gov, identifier NCT05557786; https://www.clinicaltrials.gov/ct2/show/NCT05557786.