Qihuang needle therapy for Parkinson's disease: a triple-arm randomized controlled trial protocol assessing efficacy and neuroplasticity via multimodal MRI

Background: Parkinson's disease (PD) is a progressive neurodegenerative disorder for which no curative therapy currently exists. Qihuang needle therapy (QNT) is a novel acupuncture technique that has demonstrated clinical promise in alleviating PD symptoms, but its neuroplasticity mechanisms remain unexplored. This trial aims to investigate the efficacy and neurological effects of the QNT via multimodal MRI. Methods: This triple-arm randomized controlled trial will enroll 69 PD patients randomized into three groups (1:1:1): verum acupuncture, sham acupuncture, or wait-list control. Patients in the verum and sham groups will receive eight treatment sessions over 4 weeks, followed by an 8-week follow-up period. The control group will not receive any acupuncture treatment throughout the trial. Clinical outcomes included the Unified Parkinson's Disease Rating Scale Part III (UPDRS-III), Non-Motor Symptoms Scale (NMSS), 39-item Parkinson's Disease Questionnaire (PDQ-39), muscle rigidity (shear-wave elastography), and gait/balance parameters (Footscan system). Multimodal MRI will evaluate neuroplasticity markers: gray matter volume, functional connectivity, white matter integrity, nigral iron deposition, and neuromelanin content. Discussion: This protocol pioneers the integration of the QNT with advanced neuroimaging to elucidate its neuroplasticity mechanisms in PD, providing high-level mechanistic evidence for the integration of the QNT into PD care and optimizing integrative treatment strategies that combine traditional Chinese and Western medicine. Clinical trial registration: (http://itmctr.ccebtcm.org.cn/), Identifier :ITMCTR2025000402.