Data_Sheet_1_A multimodal MRI study of XNKQ acupuncture for limb dysfunction after ischemic stroke: a randomized controlled study protocol.doc

IntroductionLimb motor dysfunction is one of the challenges in rehabilitation after cerebral ischemic stroke (CIS) and greatly affects the quality of life of patients. This study aims to investigate the central mechanisms of the curative effect with multimodal magnetic resonance imaging (MRI), which will provide additional evidence to support the application of Xingnao Kaiqiao (XNKQ) acupuncture.
Methods and analysisThis trial is a randomized controlled trial. Patients who meet the criteria will be recruited and randomly divided into 2 groups. One group will receive acupuncture treatment and another group will not receive acupuncture treatment. Both groups will receive conventional treatment. In addition, 20 healthy individuals will be recruited who will not receive any treatment. The total course of treatment is 14 days. The primary outcome is multimodal MRI analysis. For safety assessment, adverse events will be observed and recorded.
Ethics and disseminationThe study involving human subjects was reviewed and approved by the Ethics Committee of IRB of The First Teaching Hospital of Tianjin University of TCM (TYLL2023[K]031). This study complied with the Declaration of Helsinki. Written informed consent about this study was provided by the participants. The results of this study will be published in a peer-reviewed journal.
Clinical trial registrationChinese Clinical Trial Registration Center (ChiCTR2300078315) https://www.chictr.org.cn/.