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Could a zap to the ear boost memory in diabetes patients?

NCT ID NCT07642518

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a mild electrical stimulation applied to the ear (via a small device) can improve memory and thinking in people with type 2 diabetes who also have mild cognitive impairment. The trial will involve 38 participants who will either receive the active stimulation or a sham (fake) version for 24 weeks. The main goal is to see if this non-invasive treatment can help slow or improve cognitive decline.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous auricular vagus nerve stimulation device
What this could lead to
If it works, this could point toward a non-drug, at-home treatment to slow memory decline in people with type 2 diabetes.
What could go wrong
This is a very small, early-stage trial with only 38 people, so results may not apply widely. The sham control group also receives a device, so the real benefit may be small or hard to detect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Type 2 diabetes mellitus 2. Meets criteria for mild cognitive impairment 3. Aged 40 to 75 years, with no gender restrictions 4. HbA1c levels between 6.5% and 9.0% 5. At least 6 years of formal education 6. Able to cooperate with and complete all cognitive and functional assessments 7. Right-handed 8. Voluntary provision of written informed consent Exclusion Criteria: 1. 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 2. 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) 3. CNS diseases, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc 4. 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 5. Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, hypoglycemic coma, etc 6. 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 7. Concurrent major illnesses, such as active or untreated malignancies, or malignancies in clinical remission for less than 5 years. 8. 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 9. Pregnant or lactating women 10. 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) 11. 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

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.