高频磁配对相关刺激促进缺血性脑卒中患者运动功能恢复的研究方案：一项单中心、假刺激随机对照试验（H2MPAS）。
High-frequency magnetic paired associated stimulation promotes motor function recovery in ischemic stroke patients: a study protocol for single-center, sham stimulation randomized controlled trials (H2MPAS).
机构信息
School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Engineering Research Center of Traditional Chinese Medicine Intelligent Rehabilitation, Ministry of Education, Shanghai, 201203, China.
出版信息
Trials. 2024 Sep 19;25(1):618. doi: 10.1186/s13063-024-08451-9.
BACKGROUND
Numerous studies have validated the clinical effectiveness of electromagnetic pairing-associated stimulation. Building upon this foundation, we have developed a novel approach involving high-frequency magnetic paired-associated stimulation, aiming to enhance clinical applicability and potentially improve efficacy. However, the clinical effectiveness of this approach remains unclear. Our objective is to demonstrate the therapeutic efficacy of this novel approach by employing high-frequency pairing to intervene in patients experiencing motor dysfunction following a stroke.
METHODS
This is a single-center, single-blind, sham stimulation controlled clinical trial involving patients with upper limb motor dysfunction post-stroke. The intervention utilizes paired magnetic stimulation, combining peripheral and central magnetic stimulation, in patients with Brunnstrom stage III-V stroke lasting from 3 months to 1 year. Evaluation of patients' upper limb motor function occurred before the intervention and after 3 weeks of intervention. Follow-up visits will be conducted after 5 weeks and 3 months of intervention. The primary outcome measure is the Action Research Arm Test, with secondary measures including the Fugl-Meyer Assessment-upper, Modified Barthel Index, modified Tardieu scale, functional near-infrared spectroscopy, and neuroelectrophysiology.
DISCUSSION
The high-frequency magnetic paired associative stimulation used in this study combined high-frequency magnetic stimulation with paired stimulation, potentially facilitating both cortical excitation through high-frequency stimulation and specific circuit enhancement through paired stimulation. As dual-coil magnetic stimulation equipment becomes increasingly popular, magnetic-magnetic paired associated stimulation may offer patients improved clinical outcomes at reduced costs.
TRIAL REGISTRATION
Chinese Clinical Trial Registry,ChiCTR2400083363. Registered on 23 April 2024.
背景
许多研究已经验证了电磁配对关联刺激的临床效果。在此基础上，我们开发了一种新的方法，涉及高频磁配对关联刺激，旨在提高临床适用性并可能提高疗效。然而，这种方法的临床效果尚不清楚。我们的目的是通过采用高频配对来干预中风后运动功能障碍的患者，证明这种新方法的治疗效果。
方法
这是一项单中心、单盲、假刺激对照的临床试验，涉及中风后上肢运动功能障碍的患者。干预措施利用配对磁刺激，结合外周和中枢磁刺激，对 Brunnstrom 阶段 III-V 中风持续 3 个月至 1 年的患者进行治疗。在干预前和干预 3 周后对患者的上肢运动功能进行评估。干预后 5 周和 3 个月进行随访。主要结局指标是动作研究上肢测试，次要指标包括 Fugl-Meyer 评估-上肢、改良巴氏指数、改良 Tardieu 量表、功能性近红外光谱和神经电生理学。
讨论
本研究中使用的高频磁配对关联刺激将高频磁刺激与配对刺激相结合，通过高频刺激促进皮层兴奋，通过配对刺激增强特定回路，可能为患者提供更好的临床效果。随着双线圈磁刺激设备的普及，磁-磁配对关联刺激可能以更低的成本为患者提供更好的临床效果。
试验注册
中国临床试验注册中心，ChiCTR2400083363。注册于 2024 年 4 月 23 日。
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