Transcutaneous Auricular Vagus Nerve Stimulation in Type 2 Diabetes With Mild Cognitive Impairment (NCT07642518) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcutaneous Auricular Vagus Nerve Stimulation in Type 2 Diabetes With Mild Cognitive Impairment
38 participantsStarted 2026-05-20
Plain-language summary
This study is a 24-week, single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial. A total of 38 patients with type 2 diabetes and mild cognitive impairment were enrolled and randomly assigned in a 1:1 ratio to either the treatment group (receiving active transcutaneous auricular vagus nerve stimulation) or the sham control group (receiving sham transcutaneous auricular vagus nerve stimulation). The primary objective of this study is to evaluate the potential disease-modifying effects of transcutaneous auricular vagus nerve stimulation on cognitive impairment in patients with type 2 diabetes.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a device that stimulates a nerve in the ear to see if it improves cognitive scores in people with both Type 2 diabetes and mild cognitive impairment — given my specific situation, does it sound like something worth discussing once it opens for enrollment?
2The trial is listed as 'not yet recruiting,' so how would we find out when it actually starts accepting participants, and is there a way to get on a notification list?
3The main thing this trial is measuring is the Montreal Cognitive Assessment score — can you explain what that test involves and whether my current MoCA score would even be in the range this study is likely looking for?
4Since this is a Phase NA study involving a non-drug device rather than a medication, what does that mean for how much safety and effectiveness data already exists for this type of ear nerve stimulation, and are there any known risks I should understand?
5While we wait to see if this trial opens, are there any standard treatments or lifestyle changes already proven to help with cognitive issues in people with Type 2 diabetes that I should be pursuing right now instead of waiting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Montreal Cognitive Assessment Scale (MoCA) score
Timeframe: Baseline, and Week 24
Trial details
NCT IDNCT07642518
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
. 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)
. 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