Transcutaneous Auricular Vagus Nerve Stimulation in Type 2 Diabetes With Mild Cognitive Impairment

This study is a 24‐week, single‐center, randomized, double‐blind, sham‐controlled,parallel‐group clinical trial aimed at investigating the potential disease‐modifyingeffects of transcutaneous auricular vagus nerve stimulation (taVNS) on cognitiveimpairment in 38 patients with type 2 diabetes mellitus (T2DM) complicated by mildcognitive impairment. Participants will be randomly assigned in a 1:1 ratio to receiveeither active taVNS (stimulation frequency: 20 Hz pulses for 10 seconds and 100 Hz pulsesfor 50 seconds per minute; 30 minutes per session, twice daily) or sham stimulation for 5days per week. All participants will continue to receive treatment based on theiroriginal glucose‐lowering therapies. The primary objective of the study is to evaluateimprovements in cognitive function, while secondary endpoints include structural andfunctional brain changes, metabolic improvements, neurodegenerative biomarkers, andsafety outcomes.Participants will undergo comprehensive cognitive and metabolic assessments at baseline,followed by a safety visit at Week 12 to monitor adverse events, treatment adherence, andmetabolic parameters. The comprehensive evaluation at Week 24 will include cognitiveassessments, neuroimaging, and metabolic profiling. During the study period,investigators will conduct weekly follow‐ups via telephone or WeChat, and participantswill attend monthly in‐clinic visits to complete examinations such as capillary bloodglucose, blood pressure, and heart rate, as well as to be inquired about treatmentadherence and adverse reactions. All rationales for decision‐making and efficacyevaluations must be thoroughly documented.