多中心、随机、双盲、假刺激对照研究经颅磁刺激与精准导航治疗多系统萎缩。

A multi-center, randomized, double-blind, sham-stimulation controlled study of transcranial magnetic stimulation with precision navigation for the treatment of multiple system atrophy.

机构信息

Department of Neurology, Xijing Hospital, Air Force Military Medical University, Xian, Shaanxi, China.

Department of Rehabilitation Medicine, Xijing Hospital, Xian, Shaanxi, China.

出版信息

Trials. 2024 Sep 30;25(1):640. doi: 10.1186/s13063-024-08458-2.

DOI:10.1186/s13063-024-08458-2

PMID:39350274

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11440687/

Abstract

BACKGROUND

Multiple system atrophy (MSA) is recognized as an atypical Parkinsonian syndrome, distinguished by a more rapid progression than that observed in Parkinson's disease. Unfortunately, the prognosis for MSA remains poor, with a notable absence of globally recognized effective treatments. Although preliminary studies suggest that transcranial magnetic stimulation (TMS) could potentially alleviate clinical symptoms in MSA patients, there is a significant gap in the literature regarding the optimal stimulation parameters. Furthermore, the field lacks consensus due to the paucity of robust, large-scale, multicenter trials.

METHODS

This investigation is a multi-center, randomized, double-blind, sham-controlled trial. We aim to enroll 96 individuals diagnosed with MSA, categorized into Parkinsonian type (MSA-P) and cerebellar type (MSA-C) according to their predominant clinical features. Participants will be randomly allocated in a 1:1 ratio to either the TMS or sham stimulation group. Utilizing advanced navigation techniques, we will ensure precise targeting for the intervention, applying theta burst stimulation (TBS). To assess the efficacy of TBS on both motor and non-motor functions, a comprehensive evaluation will be conducted using internationally recognized clinical scales and gait analysis. To objectively assess changes in brain connectivity, functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) will be employed as sensitive indicators before and after the intervention.

DISCUSSION

The primary aim of this study is to ascertain whether TBS can alleviate both motor and non-motor symptoms in patients with MSA. Additionally, a critical component of our research involves elucidating the underlying mechanisms through which TBS exerts its potential therapeutic effects.

ETHICS AND DISSEMINATION

All study protocols have been reviewed and approved by the First Affiliated Medical Ethics Committee of the Air Force Military Medical University (KY20232118-F-1).

TRIAL REGISTRATION

Chinese Clinical Trial Registry ChiCTR2300072658. Registered on 20 June 2023.

摘要

背景

多系统萎缩（MSA）被认为是一种非典型的帕金森综合征，与帕金森病相比，其进展更为迅速。不幸的是，MSA 的预后仍然很差，目前尚无全球公认的有效治疗方法。尽管初步研究表明，经颅磁刺激（TMS）可能缓解 MSA 患者的临床症状，但在 TMS 的最佳刺激参数方面，文献中存在很大空白。此外，由于缺乏强有力的、大规模的多中心试验，该领域尚无共识。

方法

本研究为多中心、随机、双盲、假刺激对照试验。我们计划纳入 96 名 MSA 患者，根据其主要临床特征分为帕金森型（MSA-P）和小脑型（MSA-C）。参与者将以 1:1 的比例随机分配至 TMS 或假刺激组。我们将利用先进的导航技术，确保干预的精确靶向，采用θ爆发刺激（TBS）。为评估 TBS 对运动和非运动功能的疗效，我们将采用国际公认的临床量表和步态分析进行全面评估。为客观评估脑连接变化，我们将在干预前后采用功能磁共振成像（fMRI）和脑电图（EEG）作为敏感指标。