VR Training to Improve Postoperative Cognitive Function in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥60;

Preoperative MRI-confirmed cerebral small vessel disease;

Scheduled to undergo non-cardiac, non-craniotomy procedures under general anesthesia;

ASA physical status classification: I-III;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual reality cognitive function training

    Device

    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.

  • Virtual scene intervention

    Device

    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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Preoperative Training GroupExperimental treatment 1 intervention
Group B: Preoperative Non-Training GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in postoperative cognitive score from baseline

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

Time frame
At admission, on postoperative day 5 (or before discharge), and at 1, 6, and 12 months postoperatively

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Peking University Third Hospital

Lead sponsor

Peking University First Hospital

Collaborator

Xuanwu Hospital, Beijing

Collaborator

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