Prospective Randomized Controlled Trial of VR Cognitive Training in Reducing Postoperative Delirium in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery

NCT06999668 | Not Yet Recruiting DMC

• 2 other identifiers: IRB00006761-M20250258TY2025014
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 2

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

Conditions

Postoperative Delirium (POD); Cerebral Small Vessel Diseases

Keywords

postoperative delirium; cerebral small vascular disease; virtual reality; cognitive function

Outcome Measures

Primary 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

  From the first day to the fifth day after surgery or from the first day after surgery to before discharge

Secondary Outcomes (4)

• Changes in postoperative cognitive function

  At enrollment (baseline) and on postoperative day 5 or prior to discharge (whichever occurs first).

• Amplitude of Low-Frequency Fluctuation（ALFF） of brain regions

  At enrollment and immediately after completion of the preoperative intervention

• Fractional Amplitude of Low-Frequency Fluctuation（fALFF) of brain regions

  At enrollment and immediately after completion of the preoperative intervention

• Regional Homogeneity（ReHo） of brain regions

  At enrollment and immediately after completion of the preoperative intervention

Study Arms (2)

Preoperative Training Group

EXPERIMENTAL

Device: Virtual reality cognitive function training

Preoperative Control Group

SHAM COMPARATOR

Device: Virtual scene intervention

Interventions

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.

Preoperative Training Group

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.

Preoperative Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University First Hospital: collaborator

Study Sites (2)

Peking university first hospital

Beijing, Beijing Municipality, China

Location

Peking university third hospital

Beijing, Beijing Municipality, China

Location

Related Publications (7)

• Chen CC, Li HC, Liang JT, Lai IR, Purnomo JDT, Yang YT, Lin BR, Huang J, Yang CY, Tien YW, Chen CN, Lin MT, Huang GH, Inouye SK. Effect of a Modified Hospital Elder Life Program on Delirium and Length of Hospital Stay in Patients Undergoing Abdominal Surgery: A Cluster Randomized Clinical Trial. JAMA Surg. 2017 Sep 1;152(9):827-834. doi: 10.1001/jamasurg.2017.1083.

  PMID: 28538964 BACKGROUND

• de Vries NM, Staal JB, van der Wees PJ, Adang EM, Akkermans R, Olde Rikkert MG, Nijhuis-van der Sanden MW. Patient-centred physical therapy is (cost-) effective in increasing physical activity and reducing frailty in older adults with mobility problems: a randomized controlled trial with 6 months follow-up. J Cachexia Sarcopenia Muscle. 2016 Sep;7(4):422-35. doi: 10.1002/jcsm.12091. Epub 2015 Dec 4.

  PMID: 27239405 BACKGROUND

• Kho W, von Haefen C, Paeschke N, Nasser F, Endesfelder S, Sifringer M, Gonzalez-Lopez A, Lanzke N, Spies CD. Dexmedetomidine Restores Autophagic Flux, Modulates Associated microRNAs and the Cholinergic Anti-inflammatory Pathway upon LPS-Treatment in Rats. J Neuroimmune Pharmacol. 2022 Jun;17(1-2):261-276. doi: 10.1007/s11481-021-10003-w. Epub 2021 Aug 6.

  PMID: 34357471 BACKGROUND

• Aranake-Chrisinger A, Avidan MS. Postoperative delirium portends descent to dementia. Br J Anaesth. 2017 Aug 1;119(2):285-288. doi: 10.1093/bja/aex126. No abstract available.

  PMID: 28854545 BACKGROUND

• Peden CJ, Miller TR, Deiner SG, Eckenhoff RG, Fleisher LA; Members of the Perioperative Brain Health Expert Panel. Improving perioperative brain health: an expert consensus review of key actions for the perioperative care team. Br J Anaesth. 2021 Feb;126(2):423-432. doi: 10.1016/j.bja.2020.10.037. Epub 2021 Jan 4.

  PMID: 33413977 BACKGROUND

• Jin Z, Hu J, Ma D. Postoperative delirium: perioperative assessment, risk reduction, and management. Br J Anaesth. 2020 Oct;125(4):492-504. doi: 10.1016/j.bja.2020.06.063. Epub 2020 Aug 11.

  PMID: 32798069 BACKGROUND

• Meara JG, Leather AJ, Hagander L, Alkire BC, Alonso N, Ameh EA, Bickler SW, Conteh L, Dare AJ, Davies J, Merisier ED, El-Halabi S, Farmer PE, Gawande A, Gillies R, Greenberg SL, Grimes CE, Gruen RL, Ismail EA, Kamara TB, Lavy C, Lundeg G, Mkandawire NC, Raykar NP, Riesel JN, Rodas E, Rose J, Roy N, Shrime MG, Sullivan R, Verguet S, Watters D, Weiser TG, Wilson IH, Yamey G, Yip W. Global Surgery 2030: evidence and solutions for achieving health, welfare, and economic development. Lancet. 2015 Aug 8;386(9993):569-624. doi: 10.1016/S0140-6736(15)60160-X. Epub 2015 Apr 26. No abstract available.

  PMID: 25924834 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium; Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhengqian Li, Associate Chief Physician

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengqian Li, Associate Chief Physician

CONTACT

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

Ziyuan Shen

CONTACT

+86 150 0220 8972; 15002208972@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)