Multimodal neuroimaging protocol to explore the neural mechanisms of Tiao Shen Li Yan acupuncture in post-stroke dysphagia: a randomized sham-controlled clinical trial.

BACKGROUND

Post-stroke dysphagia (PSD) remains a frequent and disabling sequela of ischemic stroke, and effective pharmacotherapy is still lacking. Acupuncture has demonstrated significant efficacy in improving swallowing function, yet its neural mechanisms remain unclear. Research into the functional reorganization of brain networks following acupuncture treatment remains insufficient.

OBJECTIVE

This protocol describes a randomized, single-blind, sham-controlled trial designed to evaluate the clinical effects and central neural mechanisms of Tiao Shen Li Yan acupuncture for PSD, using multimodal neuroimaging with resting-state functional MRI (rs-fMRI) and diffusion tensor imaging (DTI).

METHODS

Forty-six PSD patients will be randomized 1:1 to active or sham acupuncture (30 minutes sessions, 5 times per week for 6 weeks). The primary outcomes are rs-fMRI and DTI metrics reflecting functional and structural connectivity changes (ALFF, ReHo, FC, FA, MD). Secondary outcomes include Standardized Swallowing Assessment (SSA), videofluoroscopic swallowing study (VFSS)-based measures, Montreal Cognitive Assessment (MoCA), and Swallowing Quality-of-Life Questionnaire (SWAL-QOL). Twenty healthy volunteers will provide baseline neuroimaging reference data.

EXPECTED

RESULTS

The study aims to clarify how Tiao Shen Li Yan acupuncture modulates structure-function coupling in swallowing-related brain networks and promotes functional reorganization of the brain, and to determine whether these imaging biomarkers correlate with clinical improvement.

DISCUSSION: By integrating clinical assessments with multimodal neuroimaging under a rigorous randomized design and by incorporating healthy controls to identify abnormal brain network sites in PSD, this study predefines structure-function coupling metrics and clinical endpoint measures to further explore the neural mechanisms of brain network reorganization underlying acupuncture treatment for PSD. This protocol may provide mechanistic evidence for acupuncture-induced neuroplasticity and support the development of treatment strategies for PSD.

TRIAL REGISTRATION: https://www.chictr.org.cn/hvshowproject.html?id=286791&v=1.1, identifier: ChiCTR2400086748.