Lin Kaiqi, Chen Jixiang, Pan Jiahui, Wang Ruihong, Wu Shibiao, Wen Wanxing, Li Yuanqing, Wang Lixin, Yuan Fang
The Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
Department of Rehabilitation Medicine, Guangzhou First People's Hospital, Guangzhou, China.
Brain Behav. 2025 Jun;15(6):e70637. doi: 10.1002/brb3.70637.
Treatment of disorders of consciousness (DOC) remains a clinical challenge. Electroacupuncture (EA) was shown to have the potential to promote the recovery of consciousness. This trial aims to explore the therapeutic effects and mechanisms of EA in patients with DOC due to traumatic brain injury (TBI) through a multimodal approach.
A total of 50 adult patients with DOC due to TBI and 25 healthy subjects will be enrolled in the study. Patients enrolled in the study will be assigned to the EA group or the sham-EA group through stratified randomization. All patients receive behavioral assessments (CRS-R and brain-computer interface), neurophysiological evaluations (EEG, somatosensory evoked potentials, brainstem auditory evoked potentials), and neuroimaging evaluations (rs-fMRI, amide proton transfer, intravoxel incoherent motion, neurite orientation dispersion and density imaging) before and after the 14-day EA or sham-EA treatment. Each healthy subject will receive a set of neurophysiological and neuroimaging examinations but no treatments. The practitioner administering EA and sham-EA is the only one aware of the grouping results. In the sham-EA group, sham-acupoints, sham-acupuncture, and sham-wire are utilized. The primary outcome measurement is the change in CRS-R score after 14 days of treatment compared with the baseline CRS-R score.
The AcuDoc trial will be the first randomized sham-controlled study to investigate the clinical benefits of EA in patients with DOC. This trial will elucidate the role of EA in the treatment of DOC due to TBI and provide evidence of its therapeutic mechanisms.
意识障碍（DOC）的治疗仍然是一项临床挑战。电针（EA）已显示出促进意识恢复的潜力。本试验旨在通过多模态方法探索电针治疗创伤性脑损伤（TBI）所致意识障碍患者的疗效及机制。
本研究将纳入50例因TBI导致DOC的成年患者和25名健康受试者。纳入研究的患者将通过分层随机分组被分配至电针组或假电针组。所有患者在接受14天电针或假电针治疗前后均接受行为评估（CRS-R和脑机接口）、神经生理学评估（脑电图、体感诱发电位、脑干听觉诱发电位）以及神经影像学评估（静息态功能磁共振成像、酰胺质子转移、体素内不相干运动、神经突方向离散度和密度成像）。每位健康受试者将接受一组神经生理学和神经影像学检查，但不接受治疗。实施电针和假电针的医生是唯一知晓分组结果的人。在假电针组中，使用假穴位、假针刺和假导线。主要结局指标是治疗14天后CRS-R评分相对于基线CRS-R评分的变化。
AcuDoc试验将是第一项研究电针治疗意识障碍患者临床益处的随机假对照研究。本试验将阐明电针在治疗TBI所致意识障碍中的作用，并提供其治疗机制的证据。
