Liao Ling-Yi, Wang Peng-Yu, Zhu Yang, Peng Qiu-Yi, Yang Man, Liu Lu, Tao Yong, Liu Jin-Jing, Fang Xiang-Qin, Gao Shi-Hao, Gao Chang-Yue
Department of Rehabilitation, Daping Hospital, Army Medical University, Chongqing, China.
Department of Health Statistics, College of Preventive Medicine, Army Medical University, Chongqing, China.
BMJ Open. 2025 Jan 2;15(1):e086300. doi: 10.1136/bmjopen-2024-086300.
Spasticity is a common complication of stroke, which is related to poor motor recovery and limitations in the performance of activities. Both transcranial magnetic stimulation (TMS) and extracorporeal shockwave therapy (ESWT) are effective treatment methods for poststroke spasticity (PSS). However, there is no existing study exploring the safety and effectiveness of TMS combined with ESWT for PSS.
This study will be a prospective, single-centre, randomised, factorial, controlled clinical trial. In this trial, 136 patients with PSS will be randomly divided into 4 groups: experimental group 1 (TMS), experimental group 2 (ESWT), experimental group 3 (ESWT+TMS) and control group, 34 patients in each group; all patients received routine rehabilitation. Outcome measures will be assessed by 4 time points: baseline (T), 2 weeks after initiation of treatment (T), 4 weeks after initiation of treatment (T) and follow-up (4 weeks after the end of treatment, T). The primary outcome is the modified Ashworth scale at T. The secondary outcomes include the modified Tardieu scale for the degree of spasticity, the Fugl-Meyer assessment scale and range of motion (ROM) for motor function, the stroke-specific quality of life scale (SS-QOL) and modified Barthel index for activities of life, cortical excitability measured by TMS-surface electromyography (EMG), cerebral cortex oxygen concentrations measured by functional near-infrared spectroscopy (fNIRS) and H/M ratio measured by EMG.
This study protocol was approved by the Ethics Committee of the Army Medical Center of PLA (Approval No. 2024-04) on 24 January 2024. The study will be disseminated through peer-reviewed publications and conference presentations.
This study was registered in the Chinese Clinical Trial Registry (https://www.chictr.org.cn/; unique identifier: ChiCTR2400080862; data: 9 February 2024; study protocol V. 2.0).
痉挛是中风的常见并发症，与运动恢复不佳及活动能力受限有关。经颅磁刺激（TMS）和体外冲击波疗法（ESWT）都是治疗中风后痉挛（PSS）的有效方法。然而，目前尚无研究探讨TMS联合ESWT治疗PSS的安全性和有效性。
本研究将是一项前瞻性、单中心、随机、析因、对照临床试验。在该试验中，136例PSS患者将被随机分为4组：实验组1（TMS）、实验组2（ESWT）、实验组3（ESWT+TMS）和对照组，每组34例；所有患者均接受常规康复治疗。结局指标将在4个时间点进行评估：基线（T0）、治疗开始后2周（T1）、治疗开始后4周（T2）和随访（治疗结束后4周，T3）。主要结局是T2时的改良Ashworth量表。次要结局包括痉挛程度的改良Tardieu量表、运动功能的Fugl-Meyer评估量表和关节活动范围（ROM）、中风特异性生活质量量表（SS-QOL）以及生活活动的改良Barthel指数、通过TMS-表面肌电图（EMG）测量的皮质兴奋性、通过功能近红外光谱（fNIRS）测量的大脑皮层氧浓度以及通过EMG测量的H/M比值。
本研究方案于2024年1月24日获得中国人民解放军陆军医疗中心伦理委员会批准（批准号：2024-04）。本研究将通过同行评审出版物和会议报告进行传播。
本研究已在中国临床试验注册中心注册（https://www.chictr.org.cn/；唯一标识符：ChiCTR2400080862；日期：2024年2月9日；研究方案版本2.0）。
