School of Life Science, Nanchang University, 330031 Nanchang, Jiangxi, China.
Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanchang University, 330036 Nanchang, Jiangxi, China.
J Integr Neurosci. 2023 Jan 11;22(1):15. doi: 10.31083/j.jin2201015.
Disorders of consciousness (DOC) are one of the clinical hallmarks of severe traumatic brain injury (TBI). DOC impair patient life quality and increase the burden on their families and society.
A double-blind, randomized, controlled clinical trial was conducted to determine the efficacy of routine rehabilitation combined with transcranial direct current stimulation (tDCS) in DOC patients after TBI. A total of 78 DOC patients were randomly divided after TBI into two groups: participants in the treatment group received routine rehabilitation combined with an active tDCS protocol. In contrast, participants in the control group received routine rehabilitation combined with a sham tDCS protocol. An anode was placed over the left dorsolateral prefrontal cortex and a cathode was placed over the right supraorbital area. The stimulation intensity was 2 mA. Both tDCS protocols lasted for eight consecutive weeks (20 minutes per day, six days per week). Patients were followed up for a further eight weeks. Glasgow Outcome Scale (GOS), Glasgow Coma Scale (GCS), brainstem auditory evoked potentials, somatosensory evoked potentials and electroencephalogram were measured at weeks zero, two, four, six, eight and sixteen from the start of tDCS.
Neither the GOS nor GCS scores differed significantly between the two groups, while brainstem auditory evoked potentials, somatosensory evoked potentials and electroencephalogram scores did.
This study found that tDCS improves some neurophysiological parameters but not clinical outcomes of DOC patients after TBI.
Chinese Clinical Trial Registry, ChiCTR1800014808 (The version is V.1.0). Registered on February 7, 2018. http://www.chictr.org.cn/showproj.aspx?proj=25003.
意识障碍(DOC)是严重创伤性脑损伤(TBI)的临床特征之一。DOC 会降低患者的生活质量,并增加其家庭和社会的负担。
我们进行了一项双盲、随机、对照临床试验,以确定常规康复联合经颅直流电刺激(tDCS)治疗 TBI 后 DOC 患者的疗效。TBI 后,78 名 DOC 患者被随机分为两组:治疗组接受常规康复联合经颅直流电刺激治疗,而对照组接受常规康复联合假经颅直流电刺激治疗。阳极置于左侧额上外侧皮质,阴极置于右侧眶上区。刺激强度为 2 mA。两种 tDCS 方案均持续 8 周(每天 20 分钟,每周 6 天)。患者在 tDCS 开始后 8 周内进行随访。在 tDCS 开始后的 0、2、4、6、8 和 16 周分别测量格拉斯哥结局量表(GOS)、格拉斯哥昏迷量表(GCS)、脑干听觉诱发电位、体感诱发电位和脑电图。
两组患者的 GOS 和 GCS 评分均无显著差异,而脑干听觉诱发电位、体感诱发电位和脑电图评分有差异。
这项研究发现,tDCS 可改善 TBI 后 DOC 患者的一些神经生理参数,但不能改善其临床结局。
中国临床试验注册中心,ChiCTR1800014808(版本 V.1.0)。注册于 2018 年 2 月 7 日。http://www.chictr.org.cn/showproj.aspx?proj=25003。