Abstract
BACKGROUND: Stroke is the second leading cause of death in the world, with high disability rate in survivors, among which ischemic stroke accounts for over 80% of the total. Limb dysfunction is a common neurological deficit symptom left by ischemic stroke. Timely rehabilitation therapy in the early recovery stage of stroke is important for neurological function improvement. Acupuncture therapy for "simultaneous treatment of phlegm and blood stasis," selecting acupoints based on pathogenic characteristics of ischemic stroke, has been applied to treat stroke patients with hemiplegia in our center, and it has exhibited significant effects. However, high-quality clinical evidence of this acupuncture strategy is still lacking. Therefore, the present study aims to evaluate the efficacy and safety of acupuncture therapy in improving limb function of patients with recovery-stage ischemic stroke. METHODS: This study will be a single-center, randomized, assessor-and-statistician-blinded, sham acupuncture-controlled clinical trial. After informed consent signing, 70 eligible patients with limb dysfunction in post-stroke recovery stage will be randomized into the treatment group or sham acupuncture group in a 1:1 ratio. The treatment course will last for 2 weeks, and the scale evaluation and EEG examination will be conducted before and after treatment. The primary outcome is the changes of limb function pre and post treatment using the modified Fugl-Meyer scale. Secondary outcomes include score changes in Berg Balance Scale, Fugl-Meyer Assessment Sensory Function Scale, Modified Ashworth Score, Barthel Index and TCM syndrome score pre and post treatment. Additionally, we will employ EEG to evaluate regulation effects of acupuncture on cortical neuronal excitability and functional connectivity across brain regions in stroke patients, and screen EEG-based biomarkers with predictive value. DISCUSSION: This study aims to evaluate the efficacy and safety of acupuncture therapy in stroke patients with hemiplegia, and to explore electrophysiological mechanisms of the therapeutic effects. The study will provide high-quality clinical evidence for the application of acupuncture therapy with acupoint combination based on the TCM theory in neurological rehabilitation for ischemic stroke. CLINICAL TRIAL REGISTRATION: itmctr.ccebtcm.org.cn, identifier ITMCTR2025001171.