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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in cognitive function (evaluated by MoCA score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: VR-Based Cognitive Training Plus Standard Diabetes Care (Device)
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.
干预措施: Traditional Paper-and-Pencil Cognitive Training Plus Standard Diabetes Care (Other)
结局指标
主要结局
Change in cognitive function (evaluated by MoCA score)
时间窗: Baseline , Week16
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.
次要结局
- Change in attention(evaluated by RBANS score)(Baseline , Week16)
- 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 Overall Cognitive Function(evaluated by RBANS score)(Baseline , Week16)
- Change in Resting-State Functional MRI(Baseline , Week16)
- Change in Olfactory Task-Based Functional MRI(Baseline , Week16)
- Change of Olfactory function(Baseline , Week16)
- Change in blood glucose(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in Glycated Hemoglobin(Baseline, Week 16)
- Change in liver function(Baseline, Week 16)
- Change in kidney function(Baseline, Week 16)
- Change in blood lipid levels(Baseline, Week 16)
- Change in insulin and C-peptide levels at fasting and 120 minutes after a meal(Baseline, Week 16)
- Percent Change in Body Weight From Baseline(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in waist and hip measurements(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in Body Composition and Fat Distribution(Baseline, Week 16)
- Change in Controlled Attenuation Parameter(Baseline, Week 16)
- Change in Liver Stiffness Measurement(Baseline, Week 16)
- Change in Hospital Anxiety and Depression Scale (HADS) Score(Baseline , Week16)
- Change in Self-Rating Anxiety Scale (SAS) Score(Baseline , Week16)
- Change in Functional Activities Questionnaire-9 (FAQ-9) Score(Baseline , Week16)
- Change in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline , Week16)
- Change in Diabetes Self-Care Activities (SDSCA) Score(Baseline , Week16)
研究者
Yan Bi
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School