Brain and behavior · 2025
Electro-Acupuncture to Treat Disorder of Consciousness (AcuDoc): Study Protocol for a Randomized Sham-Controlled Trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Lin Kaiqi, Chen Jixiang, Pan Jiahui, Wang Ruihong, Wu Shibiao, Wen Wanxing, Li Yuanqing, Wang Lixin, Yuan Fang
Аннотация
BACKGROUND: 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.
METHODS: 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.
DISCUSSION: 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.
METHODS: 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.
DISCUSSION: 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.