The Cognitive Protective Effect of VR-based Cognitive Traini...

About this study

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.

Condition: Type 2 Diabetes Mellitus (T2DM), Mild Cognitive Impairment (MCI)
Tested: VR-Based Cognitive Training Plus Standard Diabetes Care, Traditional Paper-and-Pencil Cognitive Training Plus Standard D...
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Who can join

Age: 45 to 80 years
Sex: All sexes
Healthy volunteers: Not accepted

Inclusion 11

Minimum age: 45 years
Maximum age: 80 years
Study condition: Type 2 Diabetes Mellitus (T2DM), Mild Cognitive Impairment (MCI)
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 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;
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.

Exclusion 11

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.

Where

1 site, 1 recruiting

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

Nanjing, Jiangsu, China

Recruiting

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