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ClinicalTrials.gov ID

NCT07370844

Lead Sponsor

Peking University Third HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

240Estimated

Last Update Posted

Jan 27, 2026Actual

Start Date

Feb 1, 2026Estimated

Primary Completion Date

Nov 30, 2027Estimated

Completion Date

Dec 31, 2027Estimated

Official Title

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

Brief Summary

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.

• Cerebral Small Vessel Disease
• Postoperative Cognitive Function

• Virtual reality cognitive function training
• Virtual scene intervention

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Peking University Third HospitalOTHER

Collaborators

Peking University First HospitalOTHER

Xuanwu Hospital, BeijingOTHER

zhengqianli@hsc.pku.edu.cn+86 156 1190 8458

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