Cerebral Small Vessel Disease, Postoperative Cognitive Function
Conditions
Keywords
Cerebral Small Vessel Disease, Postoperative Cognitive Function, Postoperative Delirium, Virtual Reality
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.
Interventions
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.
Sponsors
Peking University Third Hospital
Peking University First Hospital
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
A third-party statistician generated the allocation sequence using R 4.3.3 with a dynamic block design (mixed block sizes of 4 and 6), stratified by study site; the randomization scheme was uploaded to the REDCap system, where patient eligibility was verified before enrollment, and upon entering patient data into REDCap, the system automatically executed the stratified randomization.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postoperative cognitive score from baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of postoperative delirium | 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 |
| Amplitude of Low-Frequency Fluctuation（ALFF） of brain regions | 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 |
| Fractional Amplitude of Low-Frequency Fluctuation（fALFF) of brain regions | 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 |
| Regional Homogeneity（ReHo） of brain regions | 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 |
Countries
China
Contacts
CONTACTZhengqian Li, Associate Chief Physician
CONTACTZiyuan Shen
PRINCIPAL_INVESTIGATORZhengqian Li, Principal Investigator
Peking University Third Hospital
Outcome results
None listed