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

January 21, 2026 updated by: Li Zhengqian, Peking University Third Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
        • Contact:
      • Beijing, China
      • Beijing, China
        • Xuanwu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age≥60;
  2. Preoperative MRI-confirmed cerebral small vessel disease;
  3. Scheduled to undergo non-cardiac, non-craniotomy procedures under general anesthesia;
  4. ASA physical status classification: I-III;
  5. No use of cognitive-enhancing medications within 3 months prior to surgery;
  6. Voluntary participation with signed informed consent

Exclusion Criteria:

  1. Contraindications to cranial MRI (e.g., cardiac pacemaker, metallic implants, etc.);
  2. Intolerance to VR equipment during pre-training adaptation (e.g., dizziness, nausea, vomiting, or other subjective discomfort);
  3. Severe visual or auditory impairment;
  4. Severe hepatic or renal dysfunction;
  5. Pre-existing neuropsychiatric disorders (e.g., schizophrenia, epilepsy, Parkinson's disease, or active delirium);
  6. Inability to complete preoperative neuropsychological assessments (e.g., dementia, deaf-mutism, or communication barriers);
  7. Use of sedatives, antidepressants, or history of psychoactive substance abuse/alcoholism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative Training Group
Device: Virtual reality cognitive function training
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.
Sham Comparator: Preoperative Non-Training Group
Device: Virtual scene intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postoperative cognitive score from baseline
Time Frame: 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
At admission, on postoperative day 5 (or before discharge), and at 1, 6, and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of postoperative delirium
Time Frame: From the first day to the fifth day after surgery or from the first day after surgery to before discharge
Follow up personnel use the Confusion Assessment Method(CAM) scale to evaluate the occurrence of postoperative delirium after anesthesia surgery
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
Time Frame: At enrollment and immediately after completion of the preoperative intervention
Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to measure changes in brain regions activation
At enrollment and immediately after completion of the preoperative intervention
Fractional Amplitude of Low-Frequency Fluctuation（fALFF) of brain regions
Time Frame: At enrollment and immediately after completion of the preoperative intervention
Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to measure changes in brain regions activation
At enrollment and immediately after completion of the preoperative intervention
Regional Homogeneity（ReHo） of brain regions
Time Frame: At enrollment and immediately after completion of the preoperative intervention
Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to assess the synchronization of neuronal activity within brain regions
At enrollment and immediately after completion of the preoperative intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Peking University First Hospital
Xuanwu Hospital, Beijing

Investigators

  • Principal Investigator: Zhengqian Li, Principal Investigator, Peking University Third Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TY2025014 (Peking University Golden Resources TWing Clinical Research Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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