Abstract
BACKGROUND: Traumatic brain injury (TBI) has become a major cause of morbidity and mortality both in China and abroad. Disorders of consciousness following severe TBI is a common refractory complication, resulting in difficult rehabilitation and poor life quality. However, effective therapeutic approaches remain limited. Although acupuncture has been widely applied in the treatment of neurological disorders in China, its efficacy and safety for consciousness recovery remain to be elucidated. METHODS: Here, we conduct a study design and protocol of a randomized, blinded, controlled study to evaluate the efficacy and safety of electroacupuncture at auricular acupoints "heart" and "brainstem" combined with body acupuncture in the consciousness recovery of patients with TBI. A total of 80 patients with initial Glasgow coma scale score between 3 and 8 points will be recruited in the trial and randomized into intervention (combined application of auricular electroacupuncture and body acupuncture) group or control (conventional treatment) group. Patients in the intervention group will receive electroacupuncture at bilateral auricular acupoints "heart" and "brainstem" (4 points in total) combined with body acupuncture in addition to conventional treatment while patients in the control group will receive conventional treatment alone for 8 weeks. The primary outcomes are changes of Glasgow coma scale score and mismatch negativity of event-related brain potentials at baseline after 4 weeks after the final treatment and 4 weeks after the final treatment. The secondary outcome measures will be changes of Barthel and FuglMeyer scores at baseline after 4 weeks after the final treatment and 4 weeks after the final treatment. The safety will also be assessed by monitoring the incidence of adverse events and changes in vital signs during the study. DISCUSSION: Results from this trial will significantly support the application of auricular acupuncture and body acupuncture in the consciousness recovery of patients with severe TBI. If found to be effective and safe, auricular acupuncture combined with body acupuncture will be a valuable complementary option for comatose patients with TBI. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR1800020245. Registered on 21 December 2018.