Acupuncture for Mild Cognitive Impairment in Vascular Parkinsonism: A Prospective, Randomized, Controlled Trial Protocol

针灸治疗血管性帕金森病轻度认知障碍:一项前瞻性、随机、对照试验方案

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Abstract

PURPOSE: Vascular parkinsonism (VP) is a form of secondary parkinsonism caused by cerebrovascular disease and is typically associated with progressive cognitive decline, which greatly disrupts patients' daily lives and well-being. Vascular parkinsonism with mild cognitive impairment (VP-MCI) represents an early and potentially reversible stage of cognitive dysfunction, and an important window for early intervention. However, effective therapies for VP-MCI remain limited. Acupuncture is a non-pharmacological intervention that has shown potential benefits for motor and cognitive functions in vascular-related disorders. This study aims to evaluate the effectiveness and safety of acupuncture in patients with VP-MCI and to explore possible mechanisms. PATIENTS AND METHODS: This is a prospective, two-center, randomized, controlled, and assessor-blinded clinical trial. A total of 105 patients with VP-MCI and 12 healthy controls will be enrolled. Patients will be randomly assigned to acupuncture, sham acupuncture, or waiting-list groups. Participants in the intervention groups will receive verum or sham acupuncture three times per week for 8 weeks (24 sessions in total), with each session lasting 30 minutes. Patients in the waiting-list group will receive acupuncture after completion of the trial. The primary outcome is the Montreal Cognitive Assessment (MoCA). Secondary outcomes include the Mini-Mental State Examination (MMSE), Part III of the Unified Parkinson's Disease Rating Scale (UPDRS-III), Activities of Daily Living (ADL), Transcranial Color-Coded Doppler (TCCD), serum neurofilament light chain (sNfL) levels, and diffusion tensor imaging (DTI). DISCUSSION: This trial is designed to provide clinical evidence for the efficacy of acupuncture in alleviating cognitive impairment in VP-MCI, and to explain its underlying mechanism. The findings are expected to support acupuncture as a potential complementary therapy for the early management of VP-MCI.

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