An interventional study of Virtual reality cognitive function training and Virtual scene intervention in Postoperative Delirium (POD) and Cerebral Small Vessel Diseases, sponsored by Peking University Third Hospital. Not yet recruiting at 2 sites in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by Peking University Third Hospital · Not applicable, Interventional, and Prevention
This clinical study investigates whether virtual reality (VR)-based cognitive training can help prevent postoperative delirium (POD) in elderly non-cardiac patients with pre-existing cerebral small vessel disease (CSVD). With the global aging population undergoing more surgical procedures, POD has emerged as a serious complication in surgical patients that can prolong hospital stays and increase the risk of developing Alzheimer's disease. The study utilizes an innovative VR system that combines eye-tracking cognitive assessment with interactive rehabilitation games to evaluate and train patients' cognitive function before non-cardiac and non-intracranial operations. Conducted at Peking University Third Hospital and First Hospital, this research specifically targets patients undergoing general surgery, orthopedic surgery and other non-intracranial/non-cardiac procedures to determine if this technology-based intervention can effectively reduce POD incidence in this population while exploring its underlying mechanisms. The findings could lead to a practical solution for protecting cognitive health in elderly patients undergoing routine surgical procedures during recovery
788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.
This study's planned enrollment of 416 is above the median of 120 across 491 interventional studies indexed under Emergence Delirium.
Browse Emergence Delirium studies →Peking University Third Hospital is the lead sponsor of 745 studies on the registry; 267 are open to participants now.
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Age ≥ 65 years; Preoperative MRI diagnosis of cerebral small vessel disease (CSVD); Scheduled to undergo non-cardiac, non-intracranial procedures under general anesthesia; Expected surgery duration > 2 hours; ASA physical status classification: I-III; No use of cognitive-enhancing medications within 3 months prior to surgery; Willing to participate and provide written informed consent.
Exclusion Criteria:
Contraindications to cranial MRI (e.g., cardiac pacemaker, metallic implants, etc.); Patients experiencing subjective discomfort (dizziness, nausea, vomiting) during VR device adaptation; Severe visual or auditory impairment; Severe hepatic or renal dysfunction; Pre-existing neuropsychiatric disorders (schizophrenia, epilepsy, Parkinson's disease, delirium, etc.); Inability to complete preoperative neuropsychological assessments (dementia, deaf-mutism, communication disorders); History of cerebrovascular events (stroke, transient ischemic attack, etc.) within 3 months prior to surgery; Current use of sedatives/antidepressants or history of psychoactive substance abuse/alcoholism.
Device: Virtual reality cognitive function training
Device: Virtual scene intervention
Participants will receive VR-based cognitive training over 4-5 days prior to surgery, with three daily 30-minute sessions (8:00-10:00 AM, 12:00-2:00 PM, and 5:00-7:00 PM), ensuring a total preoperative training duration ≥6 hours. The intervention utilizes an immersive VR environment that simulates real-world scenarios and tasks. Training modules target multiple cognitive domains, including memory, executive function, calculation, and abstract reasoning, designed as engaging, game-like activities with a gradual learning curve. Each participant's regimen is personalized based on baseline cognitive assessments or physician prescriptions, adhering to the "6-hour rule" for standardized efficacy evaluation. The system incorporates adaptive difficulty adjustment, dynamically modifying task complexity in response to real-time performance.
The control group will receive non-interactive VR exposure using identical equipment and session duration as the training group (3×30-minute daily sessions for 4-5 days, totaling ≥6 hours), with all interactive functions disabled to eliminate potential media-related biases (e.g., 2D/3D cognitive load differences from tablet-based interventions) and ensure between-group differences stem solely from interactive training while maintaining blinding integrity through equivalent hardware deployment.
Occurrence of postoperative delirium
Follow up personnel use the Confusion Assessment Method(CAM) scale to evaluate the occurrence of postoperative delirium after anesthesia surgery
Time frame: From the first day to the fifth day after surgery or from the first day after surgery to before discharge
Changes in postoperative cognitive function
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).
Time frame: At enrollment (baseline) and on postoperative day 5 or prior to discharge (whichever occurs first).
Amplitude of Low-Frequency Fluctuation（ALFF） of brain regions
Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to measure changes in brain regions activation
Time frame: At enrollment and immediately after completion of the preoperative intervention
Fractional Amplitude of Low-Frequency Fluctuation（fALFF) of brain regions
Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to measure changes in brain regions activation
Time frame: At enrollment and immediately after completion of the preoperative intervention
Regional Homogeneity（ReHo） of brain regions
Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to assess the synchronization of neuronal activity within brain regions
Time frame: At enrollment and immediately after completion of the preoperative intervention
Plan to share: Yes
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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