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

Официальное название

The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment：A Prospective, Randomized, Open-Label, Parallel-Group Pilot Study

Обзор

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.

Подробное описание

As China's aging population continues to grow, type 2 diabetes Mellitus (T2DM) has become a serious health threat to the country's elderly. The risk of dementia rises rapidly with age among T2DM patients. Mild cognitive impairment (MCI) is a critical transitional stage between normal aging and dementia; early intervention can effectively slow disease progression and reduce the risk of developing dementia. Against this backdrop, non-pharmacological interventions such as cognitive training have become a key pillar of early intervention due to their high safety profile and ease of implementation. Traditional paper-and-pencil cognitive training is limited by the lack of immersive, real-world scenarios and unsatisfactory patient compliance. Virtual reality technology, with its immersive and interactive features, has shown favorable outcomes in cognitive rehabilitation for MCI patients. Nevertheless, specialized VR cognitive training programs tailored for T2DM combined with MCI are currently lacking.

This study aims to evaluate the cognitive-protective efficacy of a customized VR-based cognitive training system integrated with diabetes self-management modules in adults with T2DM and MCI. The system combines multi-sensory cognitive training with diabetes diet management education to improve cognitive function, metabolic parameters and diabetes self-management ability simultaneously. The safety and participant adherence of this customized VR training system are also verified systematically in the trial.

A total of 40 eligible participants are enrolled and randomized in a 1:1 ratio to either the VR cognitive training group or the traditional paper-and-pencil cognitive training group. The intervention period lasts 16 weeks. All participants maintain stable glucose-lowering regimens for no less than 3 months before enrollment and throughout the trial, and receive standardized weekly diabetes health education. Weekly follow-ups are conducted via verbal communication, telephone or WeChat to monitor glycemic control, adverse events and training adherence.

Participants in the VR cognitive training group use a customized VR cognitive training system developed by the research team. The system is equipped with an HTC VIVE Pro Eye head-mounted display, handheld controllers, spatial positioning base stations and a 360° rotating seat, and its supporting software is developed based on the Unity3D engine. Individualized training plans are generated according to participants' metabolic parameters including height, weight, physical activity level and diabetes duration, and training difficulty is adjusted dynamically based on task completion rate and response time of each session. The training consists of four core modules: (1) VR supermarket/canteen module, which combines diabetes diet management training with executive function, memory and calculation ability training; (2) multi-sensory object finding and difference detection module for the training of attention, visual span and cross-modal association ability; (3) mindfulness healing garden module, which relieves negative emotions through virtual natural scenes, soothing audio and relaxing scents; (4) comprehensive cognitive training module targeting memory and processing speed via digit span test, trail making test and other tasks. Training is delivered twice a week, with each session lasting 30 to 60 minutes. Participants in the control group receive frequency- and duration-matched paper-and-pencil cognitive training under full guidance from research staff throughout each session.

Assessments are performed at baseline and upon completion of the 16-week intervention, with interim follow-ups arranged at the 4th, 8th and 12th weeks to evaluate training adherence and diabetes self-management ability. The primary endpoint is the between-group difference in the change in Montreal Cognitive Assessment (MoCA) total score from baseline to week 16. Secondary endpoints cover changes in domain-specific cognitive functions (assessed by the Repeatable Battery for the Assessment of Neuropsychological Status \[RBANS\], digit span test, Stroop Color-Word Test and Trail Making Test), olfactory function (olfactory threshold, identification and recall scores), brain structural measurements and resting-state functional network connectivity (assessed via 3.0T functional magnetic resonance imaging \[fMRI\]), glycemic and lipid metabolic parameters (HbA1c, fasting and postprandial blood glucose, insulin, C-peptide and lipid profile), body composition, sleep quality, anxiety and depressive symptoms, as well as diabetes self-management behaviors. Safety assessments include monitoring the type, incidence, severity and causality of adverse events throughout the trial, together with regular detection of vital signs and laboratory indicators including liver and kidney function.

Вмешательства

• Устройство VR-Based Cognitive Training Plus Standard Diabetes Care
  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 dynamica
• Другое 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 (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.

Первичные конечные точки

• Change in cognitive function (evaluated by MoCA score) [Срок оценки: Baseline , Week16]

Вторичные конечные точки (12)

• Chang in Immediate Memory(evaluated by RBANS score) [Срок оценки: Baseline , Week16]
• Change in Visual-Spatial/Structural Ability(evaluated by RBANS score) [Срок оценки: Baseline , Week16]
• Change in verbal function (evaluated by RBANS score) [Срок оценки: Baseline , Week16]
• Change in delayed memory(evaluated by RBANS score) [Срок оценки: Baseline , Week16]
• Change in attention(evaluated by RBANS score) [Срок оценки: Baseline , Week16]
• Change in Overall Cognitive Function(evaluated by RBANS score) [Срок оценки: Baseline , Week16]
• Change in Resting-State Functional MRI [Срок оценки: Baseline , Week16]
• Change in Olfactory Task-Based Functional MRI [Срок оценки: Baseline , Week16]
• Change of Olfactory function [Срок оценки: Baseline , Week16]
• Change in blood glucose [Срок оценки: Baseline, Week 4, Week 8, Week 12, Week 16]
• Change in Glycated Hemoglobin [Срок оценки: Baseline, Week 16]
• Change in liver function [Срок оценки: Baseline, Week 16]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medi — Нанкин

Идентификаторы

NCT: NCT07650318 · 2026-0608-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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