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

NCT07650318 | Recruiting

• 1 other identifier: 2026-0608-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

A single-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 (16 weeks of individualized VR training with dynamic difficulty, 2 sessions/week, 30-60 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 16-week follow-up. Secondary endpoints include changes in individual cognitive domains (memory, executive function, attention, processing speed), 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.

Conditions

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

Keywords

Cognition; Cognitive training; Functional MRI; Virtual reality (VR) technology

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function (evaluated by MoCA score)

  Whether MoCA scores in the two groups of Type 2 diabetes mellitus patients with MCI after intervention were different from those before treatment and the difference of changes between the two groups. The MoCA scale evaluates overall cognitive function, with a total score of 30. Generally, subjects scoring ≥26 points are considered as normal cognition,while between 19-25 points as mild cognitive impairment. An extra point is added If the subject has less than 12 years of education.

  Baseline , Week16

Secondary Outcomes (25)

• Chang in Immediate Memory(evaluated by RBANS score)

  Baseline , Week16

• Change in Visual-Spatial/Structural Ability(evaluated by RBANS score)

  Baseline , Week16

• Change in verbal function (evaluated by RBANS score)

  Baseline , Week16

• Change in delayed memory(evaluated by RBANS score)

  Baseline , Week16

• Change in attention(evaluated by RBANS score)

  Baseline , Week16

Other Outcomes (2)

• Change in Simulator Sickness Questionnaire (SSQ)

  Baseline , Week 4, Week 8 , Week 12 , Week16

• Change in VR Experience Acceptance Scale

  Baseline, Week 4, Week 8, Week 12, Week 16

Study Arms (2)

VR-Based Cognitive Training Plus Standard Diabetes Care

EXPERIMENTAL

Participants will receive customized virtual reality (VR)-based cognitive training in addition to standard diabetes care and weekly structured health education for 16 weeks.

Device: VR-Based Cognitive Training Plus Standard Diabetes Care

Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care

ACTIVE COMPARATOR

Device: Traditional Paper-and-Pencil Cognitive Tasks Participants will complete standardized paper-and-pencil cognitive training tasks targeting the same cognitive domains as the VR group. Training will be administered twice weekly for 30-60 minutes per session for 16 weeks, with full guidance from trained research staff throughout each session to ensure standardization.

Other: Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care

Interventions

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 30-60 minutes per session for 16 weeks, with full guidance from trained research staff throughout each session to ensure standardization.

Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care

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 30-60 minutes per session for 16 weeks.

VR-Based Cognitive Training Plus Standard Diabetes Care

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yan Bi, MD, PhD

CONTACT

6-25-83-105302; biyan@nju.edu.cn

Zhou Zhang, MD, PhD

CONTACT

(86) 25-83106666; zhangzhou@smail.nju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 18, 2026

Record last verified: 2026-06

Locations

CN (1)