Abstract：
Trigeminal 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.
This study aimed to investigate the therapeutic effects of TNS in pDoC caused by stroke, trauma, and anoxia.
A 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.
The 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.
The results of this study indicate that TNS could increase local brain metabolism and may promote functional recovery in patients with prolonged disorders of consciousness.
Name of the registry: Chinese Clinical Trial Registry.
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.
This study aimed to investigate the therapeutic effects of TNS in pDoC caused by stroke, trauma, and anoxia.
A 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.
The 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.
The results of this study indicate that TNS could increase local brain metabolism and may promote functional recovery in patients with prolonged disorders of consciousness.
Name of the registry: Chinese Clinical Trial Registry.
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.
摘要：
背景：三叉神经刺激（TNS）已被提出作为昏迷觉醒的有希望的干预措施。然而,TNS对长期意识障碍（pDoC）患者的影响尚不清楚。
目的：本研究旨在探讨TNS对卒中引起的pDoC的治疗作用。创伤,和缺氧。
方法：将60名年龄在18岁以上的处于植物人状态或最低意识状态的患者（男性=25，女性=35）随机分配到TNS组（N=30）或假TNS组（N=30）。干预4周,随访8周。在基线和第2、4、8和12周评估作为主要结果的格拉斯哥昏迷量表（GCS）和昏迷恢复量表修订（CRS-R）评分。
结果：TNS组CRS-R的评分随时间的变化（2周：平均差=0.9，95％CI=[0.3，1.5]，P=0.006；4周：1.6，95%CI=[0.8，2.5]，P<0.001；8周：平均差=2.4，95%CI=[1.3，3.5]，P<0.001；12周：平均差=2.3，95%CI=[1.1，3.4]，P<0.001）和GCS（4周：平均差=0.7，95%CI=[0.3，1.2]，P=0.002；8周：平均差=1.1，95%CI=[0.6，1.7]，P<0.001；12周：1.1，95%CI=[0.5，1.7]，P=0.003）高于假手术组。FDG-PET显示右侧海马旁皮质的代谢，右前叶,TNS组双侧中扣带皮质明显增多。
结论：这项研究的结果表明，TNS可以增加长期意识障碍患者的局部脑代谢，并可能促进功能恢复。
■注册中心名称：中国临床试验注册中心。
背景：ChiCTR1900025573。研究提交给注册表的日期：2019-09-01。首例患者入组日期为2021-01-20。
目的：本研究旨在探讨TNS对卒中引起的pDoC的治疗作用。创伤,和缺氧。
方法：将60名年龄在18岁以上的处于植物人状态或最低意识状态的患者（男性=25，女性=35）随机分配到TNS组（N=30）或假TNS组（N=30）。干预4周,随访8周。在基线和第2、4、8和12周评估作为主要结果的格拉斯哥昏迷量表（GCS）和昏迷恢复量表修订（CRS-R）评分。
结果：TNS组CRS-R的评分随时间的变化（2周：平均差=0.9，95％CI=[0.3，1.5]，P=0.006；4周：1.6，95%CI=[0.8，2.5]，P<0.001；8周：平均差=2.4，95%CI=[1.3，3.5]，P<0.001；12周：平均差=2.3，95%CI=[1.1，3.4]，P<0.001）和GCS（4周：平均差=0.7，95%CI=[0.3，1.2]，P=0.002；8周：平均差=1.1，95%CI=[0.6，1.7]，P<0.001；12周：1.1，95%CI=[0.5，1.7]，P=0.003）高于假手术组。FDG-PET显示右侧海马旁皮质的代谢，右前叶,TNS组双侧中扣带皮质明显增多。
结论：这项研究的结果表明，TNS可以增加长期意识障碍患者的局部脑代谢，并可能促进功能恢复。
■注册中心名称：中国临床试验注册中心。
背景：ChiCTR1900025573。研究提交给注册表的日期：2019-09-01。首例患者入组日期为2021-01-20。
