Stroke is currently recognized as the second leading cause of disability and mortality worldwide (1), with acute ischemic stroke accounting for approximately 85% of cases (2). In China, the incidence of stroke has been increasing annually over the past 30 years, making it the leading cause of death in the country (3). Stroke is characterized by high incidence rates, high recurrence rates, high disability rates, and high case fatality rates (4). Acute ischemic stroke (AIS) refers to a group of syndromes caused by various factors leading to impaired blood supply to brain tissue (5). This impairment triggers a series of cascade reactions, resulting in ischemic and hypoxic necrosis in the brain, as well as neurological deficits in clinical practice (6). The current preferred treatment methods include intravenous thrombolysis and intravascular intervention therapy (7). However, treatment for AIS is often delayed due to factors such as low public awareness, a narrow thrombolysis time window, and strict eligibility criteria for thrombolysis. Only 21.5% of AIS patients in China arrive at the emergency department within 3 h of onset, and 12.6% are eligible for thrombolysis treatment, with fewer than 3% actually receiving it. The average interval between patient arrival at the emergency department and the administration of thrombolytic drugs is 116 min, significantly longer than in developed countries (8). Very few patients in China receive timely and effective thrombolytic therapy within the designated time window; therefore, it is essential for these patients to seek alternative treatments. Acute cerebral infarction is classified as a type of “stroke” in traditional Chinese medicine. Acupuncture, an important adjunctive treatment during the acute phase of cerebral infarction (9), has been shown to promote collateral circulation and improve brain circulation and metabolism to some extent (10). Currently, some scholars recommend initiating acupuncture treatment as soon as the patient’s vital signs stabilize (11). Therefore, in the early stages of acute ischemic stroke, when thrombolysis is no longer feasible and medical conditions are underdeveloped, acupuncture may offer timely intervention to mitigate the extent of cerebral infarction, reduce sequelae, and decrease the likelihood of functional disability, thereby conserving social resources (12).

The National Institutes of Health Stroke Scale (NIHSS) (19, 20), consists of 11 assessment items: degree of consciousness, ability to answer questions, ability to follow instructions, eye movements, visual fields, facial muscle strength, upper and lower extremity motor function, limb coordination, sensory functioning, speech, phonology, and sensory neglect. Each item is scored on a scale of 0 to 4, resulting in a total score ranging from 0 to 42, with higher scores indicating more severe neurological damage. Scores of 0–1 indicate normal or near-normal status; 2–4 indicate mild stroke; 5–15 indicate moderate stroke; 15–20 indicate moderate to severe stroke; and scores of 20 or more indicate severe stroke, with higher scores reflecting more severe conditions. To ensure the reliability and consistency of the NIHSS scoring, all assessors will undergo standardized training. The training will cover a detailed explanation of the scoring criteria, common scoring errors, and methods to avoid bias. The process will ensure that assessors fully understand the meaning of each scoring item and can accurately apply it during the actual assessment. After the training, assessors will be tested through both written exams and practical scoring to verify their proficiency. Additionally, the results of consistency tests, including the Kappa value (which reflects the strength of consistency, with values typically >0.75 indicating strong consistency), will be provided to evaluate the inter-rater reliability of the scoring.

Acupuncture, as a therapeutic method, has a history of over 3,000 years and is widely used in China and other Asian countries for disease prevention and treatment. Acupuncture can be used to treat a variety of internal and external diseases. Currently, it is commonly used in clinical practice for stroke treatment and various pain disorders. Recent large-scale, multi-center clinical trials have shown that acupuncture has a significant therapeutic effect in treating acute ischemic stroke patients. In particular, electroacupuncture demonstrates protective effects on cerebral ischemic injury, such as improving blood circulation, reducing infarct size, and inhibiting inflammatory responses (29). In recent years, numerous animal experiments and clinical studies have revealed the molecular and biophysical interactions of acupuncture or electroacupuncture in alleviating cerebral ischemic injury. Acupuncture intervention can significantly reduce infarct size, improve cerebral blood circulation, promote regional energy metabolism, regulate lipid metabolism, resist cerebral free radical damage, inhibit cortical apoptosis, reduce excitatory amino acids, decrease neurotoxicity, alleviate cerebrovascular immune-inflammatory responses, and promote the proliferation and differentiation of neural stem cells (30). In the treatment of pain, a study has also evaluated the efficacy and safety of acupuncture point stimulation in the treatment of gastric cancer pain for the first time. This study included 11 randomized controlled trials with 768 patients, divided into acupuncture point stimulation treatment and drug control groups. The study results showed that the acupuncture point stimulation treatment group had better efficacy than the drug control group, with a greater reduction in the NRS score. No serious adverse events were reported in the acupuncture point stimulation treatment group, and it demonstrated better control of adverse reactions (31). Other clinical studies have shown that acupuncture has a positive effect in relieving myofascial pain (32). The mechanisms of action differ between stroke and pain treatments. Acupuncture alleviates neuroinflammatory responses by stimulating vagal nerve activity and cholinergic anti-inflammatory pathways, which may be a focus of future research. Electroacupuncture promotes neuroprotection and neuroregeneration, acting through various mechanisms following ischemic brain injury.

In pain management, its mechanisms are focused on peripheral and central pathways, including reducing pain transmission and enhancing the release of endogenous opioids. In the fields of cancer pain, neurological diseases, and post-stroke recovery, acupuncture demonstrates increasing therapeutic advantages, not only improving the quality of life for patients but also offering more treatment options. However, the clinical application of acupuncture still faces many challenges, including the need for more clinical studies to further validate its efficacy and mechanisms.

The aim of this study is to determine whether acupuncture could improve vascular function in patients with AIS, thereby reducing NIHSS scores and preventing further disease progression. In this randomized controlled trial, we aim to improve patients’ neurological function and daily living abilities through acupuncture. To achieve this, we selected a series of scales and outcomes to comprehensively assess the efficacy of acupuncture. To objectively assess stroke severity, we selected the NIHSS as the primary outcome, a scale that comprehensively evaluates patients’ stroke conditions. To assess the quality of daily life, we employee the Modified Barthel Index (MBI) and the Modified Rankin Scale (mRS) as secondary outcomes.

The emerging therapeutic approach for ischemic stroke focuses on vasoprotective mechanisms and promoting neovascularization. To achieve this, neovascularization must be induced through various pathways, such as promoting the expression of VEGF and EPCs, or creating favorable conditions by inhibiting the expression of ES and inflammatory factors. Downregulation of inflammatory factors and ES expression can reduce vascular injury. Additionally, the proliferation and migration of EPCs directly promote neovascularization and mobilize factors like VEGF to facilitate tissue protection and blood vessel formation. VEGF is a key regulator of angiogenesis, and acupuncture may promote VEGF release by activating the PI3K/Akt and ERK1/2 signaling pathways, thereby enhancing vascular regeneration in ischemic regions. Additionally, ES, as an angiogenesis inhibitor, may play a role in the balance of vascular remodeling regulated by acupuncture. CD14+ and CD14- monocytes are essential in inflammation and vascular repair processes, and acupuncture may modulate their functions by influencing the Toll-like receptor 4 (TLR4) and nuclear factor-κB (NF-κB) signaling pathways, exerting anti-inflammatory and vascular protective effects.

Acupuncture improves blood and oxygen supply to the ischemic hemiparesis (33), effectively protects cerebral blood vessels, and restores brain function (34). Acupuncture has been widely used to treat stroke sequelae; however, its therapeutic effects and specific vascular protection mechanisms during the acute stage of stroke remain poorly understand. Existing studies suggest that potential vascular protection mechanisms can be categorized as follows: first, the effects of pro-angiogenic factors, including the regulation of VEGF/VEGFR (35), angiopoietin and its receptor Ang/Tie, basic fibroblast growth factor (bFGF), Apelin/APJ in vascular endothelial cells, and the expression of endothelial progenitor cells (EPCs) as well as the regulation of the Wnt/β-catenin signaling pathway; second, the effects of inhibitory angiogenesis factors, primarily characterized by reduction of endostatin (ES) expression (36). Intervention with endothelial progenitor cells (EPCs) using “acupuncture serum” collected from acupuncture points resulted in a significant increase in the proliferation, migration, and adhesion of these EPCs (37), indicating that acupuncture promotes angiogenesis following cerebral ischemia. EPCs can be derived from the CD14+ and CD14-cell subsets of adult peripheral blood mononuclear cells. Both subsets can express marker proteins and differentiate into endothelial cells under the stimulation of growth factors, thus promoting neovascularization. However, it remains unclear whether acupuncture can effectively increase the expression levels of CD14+ and CD14- cells in peripheral blood mononuclear cells, leading to the formation of EPCs. This study aims to determine whether acupuncture can promote blood vessel regeneration by increasing the expression of these CD14+ and CD14- cells, thereby enhancing vascular protection.

During the acute phase of cerebral infarction, blood–brain barrier damage and endothelial cell degeneration occur in patients with acute ischemic stroke (AIS), accompanied by elevated levels of TNF-α and IL-1β (37). To elucidate the vasoprotective mechanism of DU meridian acupuncture, the levels of inflammatory factors TNF-α and IL-1βas well as vascular endothelial growth factor (VEGF), endothelial repressor (ES) expression, and CD14+ and CD14- cell levels in peripheral blood mononuclear cells (28). These serve as serological indicators for assessing improvements in vascular health.

The trial aims to assess the efficacy of DU meridian acupuncture in treating AIS and to explore whether this acupuncture method provides vascular and brain protection by effectively inhibiting inflammation, reducing apoptosis, and promoting the generation and reconstruction of collateral circulation. These findings may offer valuable insights for the development clinical treatment options for ischemic stroke and for further investigation into the underlying mechanisms of these effects. While this study focuses on comparing acupuncture with guideline-recommended baseline treatment (antiplatelet and lipid-lowering therapy), future research could benefit from exploring other treatment strategies with potential vascular protective mechanisms. Therapies such as intensified blood pressure control, endothelial-protective agents (e.g., cilostazol), or non-pharmacological interventions (e.g., aerobic exercise) could be further investigated to deepen our understanding in future studies.