Clinical trial NCT06999668: Prospective Randomized Controlled Trial of VR Cognitive Training in Reducing Postoperative Delirium in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery
Official title: Prospective Randomized Controlled Trial of VR Cognitive Training in Reducing Postoperative Delirium in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Delirium (POD)
Cerebral Small Vessel Diseases
Keywords: postoperative delirium
cerebral small vascular disease
virtual reality
cognitive function
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
First posted: 2025-05-31
Enrollment: 416
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

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.

Primary outcomes:
measure: Occurrence of postoperative delirium
timeFrame: From the first day to the fifth day after surgery or from the first day after surgery to before discharge
Secondary outcomes:
measure: Changes in postoperative cognitive function
timeFrame: At enrollment (baseline) and on postoperative day 5 or prior to discharge (whichever occurs first).
measure: Amplitude of Low-Frequency Fluctuation（ALFF） of brain regions
timeFrame: At enrollment and immediately after completion of the preoperative intervention
measure: Fractional Amplitude of Low-Frequency Fluctuation（fALFF) of brain regions
timeFrame: At enrollment and immediately after completion of the preoperative intervention
measure: Regional Homogeneity（ReHo） of brain regions
timeFrame: At enrollment and immediately after completion of the preoperative intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university first hospital
state: Beijing
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Zhengqian Li, Associate Chief Physician
role: PRINCIPAL_INVESTIGATOR
References:
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