A Prospective Randomized Controlled Trial of VR Training to Improve Postoperative Cognitive Function in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Change in postoperative cognitive score from baseline
研究概览
简要总结
This clinical study aims to investigate whether virtual reality (VR)-based cognitive training can help improve postoperative cognitive function in elderly non-cardiac surgery patients with pre-existing cerebral small vessel disease (CSVD). As the global aging population undergoes an increasing number of surgical procedures, perioperative neurocognitive disorders (PND) have emerged as a serious complication among surgical patients, potentially prolonging hospital stays and increasing the risk of developing Alzheimer's disease. The study employs an innovative VR system that integrates eye-tracking cognitive assessment with interactive rehabilitation games to evaluate and train patients' cognitive function prior to non-cardiac and non-cranial surgeries. Conducted at Peking University Third Hospital, Peking University First Hospital, and Xuanwu Hospital of Capital Medical University, this research specifically targets patients undergoing general surgery, orthopedic surgery, and other non-cranial/non-cardiac procedures. It seeks to validate whether this technology-based intervention can effectively enhance postoperative cognitive function in this population while exploring its underlying mechanisms. The findings may offer a practical solution for protecting cognitive health in elderly patients during recovery from routine surgical procedures.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative MRI-confirmed cerebral small vessel disease;
- •Scheduled to undergo non-cardiac, non-craniotomy procedures under general anesthesia;
- •ASA physical status classification: I-III;
- •No use of cognitive-enhancing medications within 3 months prior to surgery;
- •Voluntary participation with signed informed consent
排除标准
- •Contraindications to cranial MRI (e.g., cardiac pacemaker, metallic implants, etc.);
- •Intolerance to VR equipment during pre-training adaptation (e.g., dizziness, nausea, vomiting, or other subjective discomfort);
- •Severe visual or auditory impairment;
- •Severe hepatic or renal dysfunction;
- •Pre-existing neuropsychiatric disorders (e.g., schizophrenia, epilepsy, Parkinson's disease, or active delirium);
- •Inability to complete preoperative neuropsychological assessments (e.g., dementia, deaf-mutism, or communication barriers);
- •Use of sedatives, antidepressants, or history of psychoactive substance abuse/alcoholism
研究组 & 干预措施
Preoperative Training Group
干预措施: Virtual reality cognitive function training (Device)
Preoperative Non-Training Group
干预措施: Virtual scene intervention (Device)
结局指标
主要结局
Change in postoperative cognitive score from baseline
时间窗: At admission, on postoperative day 5 (or before discharge), and at 1, 6, and 12 months postoperatively
Trained research personnel (certified by neurologists) administer the Montreal Cognitive Assessment (MoCA) to evaluate eight cognitive domains (visuospatial ability, executive function, memory, attention, calculation, language, abstract thinking, and orientation), with total scores ranging 0-30 (normal cognition defined as ≥26).We defined an increase in MoCA of ≥ 2 points as cognitive improvement
次要结局
- Occurrence of postoperative delirium(From the first day to the fifth day after surgery or from the first day after surgery to before discharge)
- Amplitude of Low-Frequency Fluctuation（ALFF） of brain regions(At enrollment and immediately after completion of the preoperative intervention)
- Fractional Amplitude of Low-Frequency Fluctuation（fALFF) of brain regions(At enrollment and immediately after completion of the preoperative intervention)
- Regional Homogeneity（ReHo） of brain regions(At enrollment and immediately after completion of the preoperative intervention)
研究者
Li Zhengqian
Associate Chief Physician
Peking University Third Hospital