Trigeminal nerve stimulation for prolonged disorders of consciousness: A randomized double-blind sham-controlled study
Trigeminal nerve stimulation for prolonged disorders of consciousness: A randomized double-blind sham-controlled study
复制标题
DOI：
10.1016/j.brs.2023.05.002
复制
发表时间：
2023-05
影响因子：
7.7
通讯作者：
Haiyun Ma;Shengnuo Fan;Zhen Xu;Xiaoting Wan;Qiangqiang Yang;Yuping Yin;Xuemeng Wu;Shaoling Wu;Hong Zhang;Chao Ma
中科院分区：
文献类型：
--
作者：
Haiyun Ma;Shengnuo Fan;Zhen Xu;Xiaoting Wan;Qiangqiang Yang;Yuping Yin;Xuemeng Wu;Shaoling Wu;Hong Zhang;Chao Ma
背景三叉神经刺激(TNS)被认为是一种很有前途的昏迷苏醒干预措施。目的探讨三七总皂苷(TNS)对中风、创伤、缺氧所致持续性意识障碍(PDoC)的治疗效果。方法将60例18岁以上植物状态或低意识状态患者随机分为TNS组(N组)和假TNS组(N组)，每组30例。干预4周，随访8周。结果TNS组昏迷评分随时间的变化(2周：平均差=0.9，95%CI=0.3，1.5，P=0.0.006；4周：1.6，95%CI=0.8，2.5，P<；0.001；8周：平均差=0.24，95%CI=0.[1.3，3.5]，P<；0.001；12周：平均差=0.23，95%CI=0.10[1.1，3.4]，P<；0.001)和GCS(4周：平均差=0.70，95%CI=0.30[0.3，1.2]，P=0.002；8周：平均差=1.1%，95%CI=0.60，1.7P<；(0.001；12周：1.1，95%CI=0.5，1.7，P=0.003)高于假手术组。18F-脱氧葡萄糖正电子发射断层扫描(FDG-PET)显示，TNS组患者右侧海马皮层、右侧楔前叶、双侧中扣带皮质的代谢明显增强。结论TNS可促进意识障碍患者的局部脑代谢，可能促进意识障碍患者的功能恢复。注册号：ChiCTR1900025573。研究报告提交登记处的日期：2019-09-01。第一个患者入选的日期是2021-01-20。
BackgroundTrigeminal nerve stimulation (TNS) has been proposed as a promising intervention for coma awakening. However, the effect of TNS on patients with prolonged disorders of consciousness (pDoC) is still unclear.ObjectiveThis study aimed to investigate the therapeutic effects of TNS in pDoC caused by stroke, trauma, and anoxia.MethodsA total of 60 patients (male =25, female =35) aged over 18 who were in a vegetative state or minimally conscious state were randomly assigned to the TNS (N = 30) or sham TNS (N = 30) groups. 4 weeks of intervention and a followed up for 8 weeks were performed. The Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R) scores as primary outcomes were assessed at baseline and at 2, 4, 8, and 12 weeks.ResultsThe score changes in the TNS group over time for CRS-R (2-week: mean difference = 0.9, 95% CI = [0.3, 1.5],P= 0.006; 4-week: 1.6, 95% CI = [0.8, 2.5],P< 0.001; 8-week: mean difference = 2.4, 95% CI = [1.3, 3.5],P< 0.001; 12-week: mean difference = 2.3, 95% CI = [1.1, 3.4],P< 0.001) and GCS (4-week: mean difference = 0.7, 95% CI = [0.3, 1.2],P= 0.002; 8-week: mean difference = 1.1, 95% CI = [0.6, 1.7],P< 0.001; 12-week: 1.1, 95% CI = [0.5, 1.7],P= 0.003) were higher than those in the sham group. 18-Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) revealed that the metabolism of the right parahippocampal cortex, right precuneus, and bilateral middle cingulate cortex was significantly increased in TNS group.ConclusionThe results of this study indicate that TNS could increase local brain metabolism and may promote functional recovery in patients with prolonged disorders of consciousness.Registration informationName of the registry: Chinese Clinical Trial Registry. Registration number: ChiCTR1900025573. The date that the study was submitted to a registry: 2019-09-01. The date when the first patient was enrolled was 2021-01-20.