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The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School • ClinicalTrials.gov ID: NCT07650318

Registry updated: 2026-09-18

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Description

A multi-center prospective, open-label, parallel-group randomized controlled trial is conducted to investigate the cognitive-protective efficacy of a novel, diabetes-specific virtual reality (VR)-based cognitive training system integrated with diet management modules, relative to frequency- and duration-matched traditional paper-and-pencil cognitive training, in adults aged 45-80 years with T2DM and amnestic/mixed mild cognitive impairment (MCI). A total of 40 eligible participants are randomly assigned 1:1 to either the intervention group (24 weeks of individualized VR training with dynamic difficulty, 2 sessions/week, 45-60 minutes/session) or the active control group (standardized paper-and-pencil cognitive tasks). All participants maintain stable glucose-lowering regimens for ≥3 months and receive standardized weekly diabetes health education. The primary endpoint is the between-group difference in the change in MoCA total score from baseline to the 24-week follow-up. Secondary endpoints include changes in individual cognitive domains (memory, executive function, attention, processing speed), Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Score , Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) Score , Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score, olfactory threshold/identification/recall, brain structural volumes and resting-state functional connectivity (assessed via 3.0T fMRI), glycemic control (HbA1c, fasting/postprandial glucose), lipid profile, body composition, sleep quality, anxiety and depressive symptoms, and diabetes self-management behaviors. The safety and participant adherence to the VR intervention are also systematically monitored.

Interventions

VR-Based Cognitive Training Plus Standard Diabetes Care (Device)
Device: Customized VR Cognitive Training System Participants will receive individualized VR cognitive training using the research team-developed system, which consists of an HTC VIVE Pro Eye head-mounted display, handheld controllers, spatial positioning base stations, and a 360° rotating seat, with software developed on the Unity3D engine. Training plans are generated based on patients' metabolic parameters (height, weight, physical activity level, diabetes duration), and difficulty is dynamically adjusted according to each session's task completion rate and response time. The training includes four core modules: (1) VR supermarket/canteen (integrating diabetes diet management); (2) multi-sensory object finding/difference detection; (3) mindfulness healing garden (multi-sensory emotional regulation); (4) comprehensive cognitive training (digit span, trail making tests). Training will be administered twice weekly for 45-60 minutes per session for 24 weeks.
Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care (Other)
Device: Traditional Paper-and-Pencil Cognitive Tasks Participants will complete standardized paper-and-pencil cognitive training tasks targeting the same cognitive domains (memory, attention, executive function, processing speed) as the VR group. Training will be administered twice weekly for 45-60 minutes per session for 24 weeks, with full guidance from trained research staff throughout each session to ensure standardization.

Eligibility criteria

Inclusion Criteria: 1. Aged 45-80 years; gender is not restricted; 2. 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; 3. Stable glycemic control regimen for 3 months or longer; 4. Completed a systematic neuropsychological assessment and meets Petersen criteria 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; 5. Has an educational level of elementary school or higher and is able to cooperate in completing the assessment, VR training, and various examinations; 6. Cooperate in undergoing magnetic resonance imaging (MRI) examinations; 7. Voluntarily participates in this study, signs an informed consent form, and is able to comply with the study protocol requirements to complete follow-up. Exclusion Criteria: 1. Suffering from other dementia-related neurological disorders (such as Alzheimer's disease, Parkinson's disease, etc.) or severe mental illness; 2. History of central nervous system disorders, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc.; 3. Severe sinusitis, space-occupying lesions in the nasopharynx, or congenital disorders affecting the sense of smell,or a history of trauma; 4. Glaucoma, severe dry eye syndrome, uncorrected strabismus, severe diabetic retinopathy,or severe motion sickness, making the user unable to tolerate VR devices; 5. History of acute diabetic complications within the past 3 months (diabetic ketoacidosis, hyperglycemic hyperosmolar state, severe hypoglycemia, etc.); 6. Severe impairment of vital organ function, including cardiac, hepatic, or renal dysfunction; 7. Pregnant or breastfeeding women, or women planning to become pregnant during the study; 8. Contraindications for MRI scans, such as the presence of metallic prostheses, pacemakers, cochlear implants, or other metallic implants, or claustrophobia; 9. Participation in other clinical trials currently or within the past 3 months; 10. Known or suspected history of allergy to study-related materials; 11. Currently taking medications intended to improve cognitive function.

Conditions

Type 2 Diabetes Mellitus (T2DM) Mild Cognitive Impairment (MCI)

Locations

Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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