Guilan Huang, Hewei Wang, Weiwei Zhao, Jinyu Yang, Ze Zheng, Wang Yao, Yu Yao, Yao Qian, Chenchen Cheng, Zhipeng Pan, Bin Su, Li Zhang
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The primary outcome was that of Fugl-Meyer assessment of the lower extremity (FMA-LE) at T3, with secondary outcomes, including those of Berg Balance Scale (BBS), modified Barthel index (MBI) and Brunnstrom scale. TecnoBody balance equipment was used to quantify sway length (SL) and sway area (SA). All outcome assessments were performed at baseline (T0), after 1 week (T1), after 2 weeks (T2) and 3 weeks (T3) of intervention. Intention-to-treat and per-protocol analyses were performed.</p><p><strong>Results: </strong>Among the 212 inpatients screened, 56 patients (age, 61.50 ± 5.41 years; 17 women, 46 ischemic) were enrolled in the study. Significant group-by-time interactions occurred, with the rTMS group displaying greater improvements than the sham group in FMA-LE (F = 2.883, P = 0.038) and BBS (F = 3.379, P = 0.020). No significant interactions were observed for MBI (F = 2.245, P = 0.085) or Brunnstrom scale (F = 1.565, P = 0.200). At T3, the rTMS group showed a 1.5 point significantly higher FMA-LE scores (95% confidence interval: 0.567-2.433, P = 0.002) compared with the sham group. TecnoBody balance assessments also showed superior results of the rTMS group for SA (F = 6.902, P < 0.001) and SL (F = 6.837, P < 0.001).</p><p><strong>Conclusions: </strong>Application of 10 Hz rTMS over the leg motor cortex with a double-cone coil holds potential to improve lower-limb motor function in subacute stroke patients.</p><p><strong>Trial registration: </strong>This trial was registered under ClinicalTrials.gov ID No. ChiCTR2100051566, prospectively registered, on September 26, 2021.</p>","PeriodicalId":16384,"journal":{"name":"Journal of NeuroEngineering and Rehabilitation","volume":"22 1","pages":"201"},"PeriodicalIF":5.2000,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12482667/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effects of 10-Hz rTMS over the leg motor cortex using a double-cone coil on lower limb motor recovery in subacute stroke: a randomised, double-blind, sham-controlled study.\",\"authors\":\"Guilan Huang, Hewei Wang, Weiwei Zhao, Jinyu Yang, Ze Zheng, Wang Yao, Yu Yao, Yao Qian, Chenchen Cheng, Zhipeng Pan, Bin Su, Li Zhang\",\"doi\":\"10.1186/s12984-025-01745-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Lower limb dysfunction following stroke poses important challenges to patients' mobility and quality of life. 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引用次数: 0
摘要
背景：脑卒中后下肢功能障碍对患者的活动能力和生活质量提出了重要的挑战。重复经颅磁刺激（rTMS）采用双锥体线圈进行深度刺激，为改善这些患者的运动恢复提供了一条有希望的途径。然而，这种方法的有效性和安全性仍未得到充分探讨。方法：共有56例亚急性脑卒中患者被随机分配到rTMS或假刺激组（每组28例），在3周内超过15个疗程。主要终点是T3时Fugl-Meyer下肢评分（FMA-LE），次要终点包括Berg平衡量表（BBS）、改良Barthel指数（MBI）和Brunnstrom量表。采用TecnoBody平衡仪量化摇摆长度（SL）和摇摆面积（SA）。所有结果评估分别在基线（T0）、干预后1周（T1）、2周（T2）和3周（T3）进行。进行意向治疗和方案分析。结果：在筛选的212例住院患者中，56例（年龄：61.50±5.41岁；女性17例，缺血性46例）纳入研究。其中，rTMS组在FMA-LE （F = 2.883, P = 0.038）和BBS （F = 3.379, P = 0.020）方面的改善显著高于sham组。MBI （F = 2.245, P = 0.085）和Brunnstrom量表（F = 1.565, P = 0.200）未观察到显著的相互作用。T3时，rTMS组FMA-LE评分较sham组显著提高1.5分（95%可信区间：0.567 ~ 2.433,P = 0.002）。TecnoBody平衡评估也显示，rTMS组对SA的疗效更好（F = 6.902， P）。结论：在腿部运动皮质上应用10hz rTMS双锥线圈有可能改善亚急性卒中患者的下肢运动功能。试验注册：本试验在ClinicalTrials.gov注册。ChiCTR2100051566，预期于2021年9月26日注册。
Effects of 10-Hz rTMS over the leg motor cortex using a double-cone coil on lower limb motor recovery in subacute stroke: a randomised, double-blind, sham-controlled study.
Background: Lower limb dysfunction following stroke poses important challenges to patients' mobility and quality of life. Repetitive transcranial magnetic stimulation (rTMS) using double-cone coils for deep stimulation offers a promising avenue for the improved motor recovery of these patients. However, the efficacy and safety of this approach remain underexplored.
Methods: A total of 56 subacute stroke patients were randomised to rTMS or sham stimulation (n = 28 per group), over 15 sessions in 3 weeks. The primary outcome was that of Fugl-Meyer assessment of the lower extremity (FMA-LE) at T3, with secondary outcomes, including those of Berg Balance Scale (BBS), modified Barthel index (MBI) and Brunnstrom scale. TecnoBody balance equipment was used to quantify sway length (SL) and sway area (SA). All outcome assessments were performed at baseline (T0), after 1 week (T1), after 2 weeks (T2) and 3 weeks (T3) of intervention. Intention-to-treat and per-protocol analyses were performed.
Results: Among the 212 inpatients screened, 56 patients (age, 61.50 ± 5.41 years; 17 women, 46 ischemic) were enrolled in the study. Significant group-by-time interactions occurred, with the rTMS group displaying greater improvements than the sham group in FMA-LE (F = 2.883, P = 0.038) and BBS (F = 3.379, P = 0.020). No significant interactions were observed for MBI (F = 2.245, P = 0.085) or Brunnstrom scale (F = 1.565, P = 0.200). At T3, the rTMS group showed a 1.5 point significantly higher FMA-LE scores (95% confidence interval: 0.567-2.433, P = 0.002) compared with the sham group. TecnoBody balance assessments also showed superior results of the rTMS group for SA (F = 6.902, P < 0.001) and SL (F = 6.837, P < 0.001).
Conclusions: Application of 10 Hz rTMS over the leg motor cortex with a double-cone coil holds potential to improve lower-limb motor function in subacute stroke patients.
Trial registration: This trial was registered under ClinicalTrials.gov ID No. ChiCTR2100051566, prospectively registered, on September 26, 2021.
期刊介绍：
Journal of NeuroEngineering and Rehabilitation considers manuscripts on all aspects of research that result from cross-fertilization of the fields of neuroscience, biomedical engineering, and physical medicine & rehabilitation.
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