Shallow Acupuncture for brainstem infarction: a randomized controlled trial protocol

Brainstem infarction is a clinically important subtype of posterior circulation infarction and is often associated with disability and poor functional recovery. Disease-specific therapeutic strategies remain limited, and rehabilitation-oriented evidence specifically targeting functional recovery in this population remains insufficient. Acupuncture has been studied and applied as an adjunctive approach for stroke rehabilitation in multiple regions; however, high-quality evidence for its use in brainstem infarction remains scarce. This trial primarily aims to evaluate whether adjunctive Shallow Acupuncture improves activities of daily living in patients with brainstem infarction; as an exploratory objective, it will examine associated neural changes assessed by resting-state functional magnetic resonance imaging (rs-fMRI) and diffusion tensor imaging (DTI).

This is a single-center, randomized, assessor- and statistician-blinded, pragmatic add-on controlled trial. A total of 62 patients with brainstem infarction will be randomly assigned in a 1:1 ratio to a conventional acupuncture group or an adjunctive Shallow Acupuncture group. In keeping with routine inpatient practice in the acupuncture department, both groups will receive standard medical management, routine rehabilitation, and conventional acupuncture, while the adjunctive Shallow Acupuncture group will additionally receive Shallow Acupuncture once daily for 14 consecutive days. The primary clinical outcome will be activities of daily living, assessed by the Barthel Index. Secondary clinical outcomes will include the National Institutes of Health Stroke Scale and the modified Rankin Scale. Exploratory indicators will include measures derived from rs-fMRI and DTI. rs-fMRI analyses will focus primarily on resting-state functional connectivity, whereas DTI analyses will focus primarily on fractional anisotropy; mean diffusivity will be examined as an exploratory diffusion metric. Clinical outcomes will be assessed at baseline, post-treatment, and 1-month follow-up, and neuroimaging assessments will be performed at baseline and post-treatment.

This study has been approved by the Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval numbers: YE2024-202-01 and YE2024-203-01). The findings will be disseminated through peer-reviewed publications and academic conferences.

https://itmctr.ccebtcm.org.cn/zh/index.html. Identifier, ITMCTR2024000456.