NCT07650318 · RECRUITING
The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment
This trial is testing whether a virtual reality brain-training program designed specifically for people with Type 2 diabetes and early memory problems works better than traditional paper-and-pencil cognitive exercises. Researchers will track memory, thinking speed, brain scans, and blood sugar control over 16 weeks. This is a Phase NA designating a non-drug device trial — it is testing whether the approach is effective, not a proven therapy.
You may qualify if
- Aged 45-80 years; gender is not restricted;
- Participants must meet the diagnostic criteria for diabetes outlined in the *Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)*, namely: patients exhibit typical symptoms of diabetes and meet one of the following conditions: 1) HbA1c ≥ 6.5%; 2) Fasting blood glucose ≥7.0 mmol/L. Fasting is defined as no caloric intake for at least 8 hours; 3) 2-hour postprandial blood glucose ≥11.1 mmol/L following an oral glucose tolerance test; 4) Random blood glucose ≥11.1 mmol/L;
- Stable glycemic control regimen for 3 months or longer;
- Completed a systematic neuropsychological assessment and met the MCI diagnostic criteria outlined in the 2018 American Academy of Neurology Guidelines for Mild Cognitive Impairment, satisfying the following conditions: 1) The patient or a caregiver subjectively perceives a decline in cognitive function; 2) Assessment results indicate impairment in one or more cognitive domains; 3) There is mild impairment in complex instrumental activities of daily living, but the patient maintains independence in basic activities of daily living; 4) Does not yet meet the diagnostic criteria for dementia;
- Has an educational level of elementary school or higher and is able to cooperate in completing the assessment, VR training, and various examinations;
- Cooperate in undergoing magnetic resonance imaging (MRI) examinations;
- Voluntarily participates in this study, signs an informed consent form, and is able to comply with the study protocol requirements to complete follow-up.
You're excluded if
- Suffering from other dementia-related neurological disorders (such as Alzheimer's disease, Parkinson's disease, etc.) or severe mental illness;
- History of central nervous system disorders, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc.;
- Severe sinusitis, space-occupying lesions in the nasopharynx, or congenital disorders affecting the sense of smell,or a history of trauma;
- Glaucoma, severe dry eye syndrome, uncorrected strabismus, severe diabetic retinopathy,or severe motion sickness, making the user unable to tolerate VR devices;
- History of acute diabetic complications within the past 3 months (diabetic ketoacidosis, hyperglycemic hyperosmolar state, severe hypoglycemia, etc.);
- Severe impairment of vital organ function, including cardiac, hepatic, or renal dysfunction;
- Pregnant or breastfeeding women, or women planning to become pregnant during the study;
- Contraindications for MRI scans, such as the presence of metallic prostheses, pacemakers, cochlear implants, or other metallic implants, or claustrophobia;
- Participation in other clinical trials currently or within the past 3 months;
- Known or suspected history of allergy to study-related materials;
- Currently taking medications intended to improve cognitive function.
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 2026-06-18