NCT07642518 · NOT YET RECRUITING
Transcutaneous Auricular Vagus Nerve Stimulation in Type 2 Diabetes With Mild Cognitive Impairment
This trial tests whether a small device clipped to the ear — stimulating the vagus nerve through the skin — can help protect cognitive function in people who have both type 2 diabetes and mild cognitive impairment. Half the participants get real stimulation, half get a sham version, and researchers measure cognitive changes over 24 weeks. This is a Phase NA exploratory trial — think of it as early-stage evidence gathering, not a proven treatment.
You may qualify if
- Type 2 diabetes mellitus
- Meets criteria for mild cognitive impairment
- Aged 40 to 75 years, with no gender restrictions
- HbA1c levels between 6.5% and 9.0%
- At least 6 years of formal education
- Able to cooperate with and complete all cognitive and functional assessments
- Right-handed
- Voluntary provision of written informed consent
You're excluded if
- Concomitant use of GLP-1 receptor agonists, Alzheimer's disease medications, anti-Parkinson's medications, antiepileptic drugs, or antipsychotic drugs within 3 months prior to screening
- Presence of dementia-related neurological disorders; current or history of clinically significant psychiatric disorders within the past 2 years (e.g., schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, personality disorders)
- CNS diseases, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc
- Severe sinusitis, nasal and sinus polyps, space-occupying lesions such as skull base or nasopharyngeal tumors; congenital diseases or history of trauma of the nose, maxillofacial region, or skull base that affect olfactory function; presence of upper respiratory tract infection symptoms (e.g., nasal congestion, rhinorrhea, fever) on the day of the MRI scan
- Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, hypoglycemic coma, etc
- Severe impairment of major organ function (e.g., heart, liver, kidneys), including any of the following: ALT and/or AST > 3×ULN. eGFR \< 45 mL/min/1.72 m² (CKD-EPI). History of unstable angina, myocardial infarction, or NYHA Class II or higher heart failure within 3 months prior to screening
- Concurrent major illnesses, such as active or untreated malignancies, or malignancies in clinical remission for less than 5 years.
- Contraindications for MRI scans (e.g., implanted metallic prostheses, claustrophobia); presence of cardiac pacemakers or other implantable medical devices; severe infection or ulceration of the auricular skin
- Pregnant or lactating women
- History of alcohol abuse, defined as an average weekly alcohol consumption exceeding 21 units for males and 14 units for females (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of distilled spirits/liquor)
- Any other conditions or factors that, in the opinion of the investigator, may confound the efficacy or safety evaluation of the study, making the participant unsuitable for enrollment
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-06-11