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
Study ID
NCT07650318
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jun 16, 2026
Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: VR-Based Cognitive Training Plus Standard Diabetes Care
    Participants will receive customized virtual reality (VR)-based cognitive training in addition to standard diabetes care and weekly structured health education for 16 weeks.
  • Active Comparator: Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care
    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.

Primary Outcome Measure

Change in cognitive function (evaluated by MoCA score) [ Time Frame: Baseline , Week16 ]

Central Contacts

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