Xu Junpeng, Liu Bin, Liu Shuzhen, Feng Zhebin, Zhang Yanyang, Liu Di, Chang Qing, Yang Haonan, Chen Yuhan, Yu Xinguang, Mao Zhiqi
Medical School of Chinese PLA, Beijing, China.
Department of Neurosurgery, The First Medical Center of Chinese PLA General Hospital, Beijing, China.
Front Neurol. 2024 Aug 13;15:1355104. doi: 10.3389/fneur.2024.1355104. eCollection 2024.
Deep brain stimulation (DBS) is a potential treatment for improving movement disorder. However, few large-sample studies can reveal its efficacy and safety. This study aims to initially explore the efficacy and safety of DBS in the mesencephalic locomotor region (MLR) on motor function in patients with post-stroke hemiplegia.
METHODS/DESIGN: This multicenter, prospective, double-blind, randomized crossover clinical trial aims to assess the safety and effectiveness of Deep Brain Stimulation (DBS) in the mesencephalic locomotor region (MLR) for patients with moderate to severe post-stroke hemiplegia. Sixty-two patients with stable disease after a year of conservative treatment will be enrolled and implanted with deep brain electrodes. Post-surgery, patients will be randomly assigned to either the DBS group or the control group, with 31 patients in each. The DBS group will receive electrical stimulation 1 month later, while the control group will undergo sham stimulation. Stimulation will be discontinued after 3 and 6 months, followed by a 2-week washout period. Subsequently, the control group will receive electrical stimulation, while the DBS group will undergo sham stimulation. Both groups will resume electrical stimulation at the 9th and 12th-month follow-ups. Post-12-month follow-up, motor-related scores will be collected for analysis, with the Fugl-Meyer Assessment Upper Extremity Scale (FMA-UE) as the primary metric. Secondary outcomes include balance function, neuropsychiatric behavior, fall risk, daily living activities, and quality of life. This study aims to provide insights into the therapeutic benefits of DBS for post-stroke hemiplegia patients.
RESULT/CONCLUSION: We proposed this study for the first time to comprehensively explore the effectiveness and safety of DBS in improving motor function for post-stroke hemiplegia, and provide evidence for DBS in the treatment of post-stroke hemiplegia. Study limitations are related to the small sample size and short study period.
Clinicaltrials.gov, identifier NCT05968248.
深部脑刺激（DBS）是改善运动障碍的一种潜在治疗方法。然而，很少有大样本研究能揭示其疗效和安全性。本研究旨在初步探讨在中脑运动区（MLR）进行DBS对中风后偏瘫患者运动功能的疗效和安全性。
方法/设计：这项多中心、前瞻性、双盲、随机交叉临床试验旨在评估深部脑刺激（DBS）在中脑运动区（MLR）对中重度中风后偏瘫患者的安全性和有效性。62名经过一年保守治疗病情稳定的患者将被纳入并植入深部脑电极。术后，患者将被随机分为DBS组和对照组，每组31人。DBS组将在1个月后接受电刺激，而对照组将接受假刺激。3个月和6个月后停止刺激，随后有2周的洗脱期。随后，对照组将接受电刺激，而DBS组将接受假刺激。两组将在第9个月和第12个月的随访中恢复电刺激。12个月随访后，收集运动相关评分进行分析，以Fugl-Meyer评估上肢量表（FMA-UE）作为主要指标。次要结果包括平衡功能、神经精神行为、跌倒风险、日常生活活动和生活质量。本研究旨在深入了解DBS对中风后偏瘫患者的治疗益处。
结果/结论：我们首次提出本研究，以全面探讨DBS改善中风后偏瘫运动功能的有效性和安全性，并为DBS治疗中风后偏瘫提供证据。研究局限性与样本量小和研究周期短有关。
Clinicaltrials.gov，标识符NCT05968248。
