Clinical efficacy study on the efficacy and safety of acupuncture for post-stroke dysphagia based on the regulation of the swallowing neural circuit: Protocol for a multicenter, open-label, randomized controlled trial

Yuhua Yan¹Guoshan Zhang¹Nan Li¹Jian Luo¹Bo Li²Lian Liu³Cai Li¹Zenghui Yue^1*Murong Zhimiao^1*

• ¹Hunan University of Chinese Medicine, Changsha, China
• ²The First Hospital of Hunan University of Chinese Medicine, Changsha, China
• ³Hunan Traditional Chinese Medical Hospital, Changsha, China

Introduction: Post-stroke dysphagia(PSD) is a common complication of stroke. Rehabilitation training and acupuncture have been suggested as current effective therapies, but high-quality evidence of acupuncture is insufficient. A meta-analysis has shown that acupuncture may be an effective adjunctive treatment for improving swallowing function, but the guidelines do not provide sufficient recommendations. Therefore, clinical and mechanism-related research on acupuncture treatment for post-stroke dysphagia should be vigorously promoted. Methods: This study is a multicenter, open-label, randomized clinical trial. A total of 115 participants will be enrolled: 100 PSD patients will be randomly allocated in a 1:1 ratio to the experimental group (acupuncture combined with basic treatment) or the control group (rehabilitation training combined with basic treatment), and 15 healthy controls will only provide baseline information without receiving any treatment. Both groups will be given a four-week intervention (three times per week). The primary efficacy outcome measure is the Functional Oral Intake Scale (FOIS). Secondary outcome measures include: Regional Homogeneity (ReHo) and Amplitude of Low-Frequency Fluctuation (ALFF) metrics from Functional Magnetic Resonance Imaging(fMRI) scans, surface electromyography (sEMG) assessments, the Swallowing Disorders-Specific Quality of Life Questionnaire (SWAL-QOL), the National Institutes of Health Stroke Scale (NIHSS), the Treatment Expectation Questionnaire (TEX-Q) and patient-reported outcomes (PRO). Additionally, the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be performed together with the Penetration-Aspiration Scale (PAS) and the Yale Pharyngeal Residue Severity Rating Scale (YPR-SRS). Outcomes will be assessed at five time 2 points: baseline, day 15 and day 30 during treatment, and 30 days and 60 days after treatment. All primary analyses will be conducted using both intention-to-treat and per-protocol approaches. Discussion: This trial will investigate the efficacy of acupuncture targeting swallowing neural circuit regulation for improving swallowing function, reducing major complications, and enhancing quality of life in patients with swallowing disorders. It will also explore the underlying neural regulatory mechanisms, evaluate the efficacy of acupuncture for post-stroke dysphagia, and provide high-quality evidence.