Supplementary file 1_Effects and central mechanisms of acupuncture for post-stroke vascular vertigo: study protocol of a multicenter, randomized, sham-controlled trial.pdf

BackgroundVascular vertigo is a common sequela following stroke, significantly impairing patients’ quality of life and rehabilitation progress. Although Western pharmaceutical treatments are widely used, their long-term efficacy is limited and associated with side effects. Acupuncture, a traditional Chinese medical therapy, has potential advantages in alleviating vertigo symptoms. This study aims to evaluate the efficacy and central mechanisms of acupuncture for post-stroke vascular vertigo (PSVV).
MethodsThis study is a multicenter, double-blind, randomized controlled trial planned to enroll 234 patients with PSVV from four subcenters. Participants will be randomly assigned in a 1:1:1 ratio to the acupuncture group, the sham acupuncture group, or the active drug group. The trial comprises a 1-week induction period, a 3-week treatment period, and follow-up periods at 8 weeks and 20 weeks. Following the induction period, the drug group will receive betahistine mesilate tablets orally, the acupuncture group will receive needling at Baihui (GV20), Fengchi (GB20), Wangu (GB12), and Taichong (LR3), and the sham acupuncture group will receive superficial needling at non-acupoints combined with blunt needle. All groups will undergo intervention 3 weeks. The primary outcome will be the Dizziness Handicap Inventory (DHI), with secondary outcomes including the Dizziness and Anxiety Rating Scale (DARS), dizziness diaries, the 36-Item Short Form Health Survey (SF-36), transcranial Doppler ultrasonography (TCD), multimodal magnetic resonance imaging (MRI), and Expectation Rating Scale (ERS). The relationship between clinical efficacy and the mechanisms of the prescribed interventions will be explored. Treatment safety will be assessed through adverse event records.
DiscussionThis trial will be the first to compare the efficacy of acupuncture, sham acupuncture, and Western medication in treating PSVV. It aims to demonstrate whether acupuncture is safe and effective for this condition and to elucidate its central nervous system mechanisms. We anticipate that this research will provide clinical evidence for the management of PSVV.
Ethics and disseminationThe Medical Ethics Committee of the Chengdu University of Traditional Chinese Medicine Affiliated Hospital has given study approval (approval no. 2025KL-062). The findings will be disseminated through publications, conferences, and briefs to professional organizations.
Clinical trial registrationhttp://itmctr.ccebtcm.org.cn, identifier ITMCTR2025001283.