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Cerebral Small Vessel DiseaseNCT07370844

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

A study testing Virtual reality cognitive function training and Virtual scene intervention in people with Cerebral Small Vessel Disease and Postoperative Cognitive Function, run by Peking University Third Hospital at 3 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Virtual reality cognitive function training and Virtual scene intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
3 sitesChina
Study dates
1 Feb 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhengqian Li, Associate Chief Physician contact

+86 156 1190 8458

zhengqianli@hsc.pku.edu.cn

China3 sites
  • Peking University First Hospital

    Beijing

    Dongliang Mu, +8617810370608, mudongliang@bjmu.edu.cn

  • Peking University Third Hospital

    Beijing

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

  • Xuanwu Hospital

    Beijing

    Wei Xiao, +86 15863946177, kitten15@126.com

Other trials in China

About this study

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

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.

Being tested
Virtual reality cognitive function training, Virtual scene intervention
Keywords
Cerebral Small Vessel Disease, Postoperative Cognitive Function, Postoperative Delirium, Virtual Reality
Medical subject headings
Cerebral Small Vessel Diseases, Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual reality cognitive function trainingDevice

    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.

  • Virtual scene interventionDevice

    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.

Study groups in NCT07370844
Study groupRoleWhat they receive
Preoperative Training GroupExperimentalNot described
Receives: Device: Virtual reality cognitive function training
Preoperative Non-Training GroupSham comparatorNot described
Receives: Device: Virtual scene intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in postoperative cognitive score from baseline

    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

    Measured: At admission, on postoperative day 5 (or before discharge), and at 1, 6, and 12 months postoperatively

Secondary outcomes (4)
  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

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

  2. Amplitude of Low-Frequency Fluctuation(ALFF) of brain regions

    Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to measure changes in brain regions activation

    Measured: At enrollment and immediately after completion of the preoperative intervention

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

    Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to measure changes in brain regions activation

    Measured: At enrollment and immediately after completion of the preoperative intervention

  4. Regional Homogeneity(ReHo) of brain regions

    Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI) was used to assess the synchronization of neuronal activity within brain regions

    Measured: At enrollment and immediately after completion of the preoperative intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07370844
Sponsor's protocol ID
TY2025014
Status last verified
Jan 2026
First submitted
14 Jan 2026
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 28538964
  • 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.

    PubMed 27239405
  • 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.

    PubMed 34357471
  • 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.

    PubMed 28854545
  • 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.

    PubMed 33413977
  • 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.

    PubMed 32798069
  • 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. Int J Obstet Anesth. 2016 Feb;25:75-8. doi: 10.1016/j.ijoa.2015.09.006. Epub 2015 Sep 30. No abstract available.

    PubMed 26597405
  • Nijsse B, Visser-Meily JM, van Mierlo ML, Post MW, de Kort PL, van Heugten CM. Temporal Evolution of Poststroke Cognitive Impairment Using the Montreal Cognitive Assessment. Stroke. 2017 Jan;48(1):98-104. doi: 10.1161/STROKEAHA.116.014168. Epub 2016 Nov 29.

    PubMed 27899753

Questions about this trial

What is this clinical trial studying?

A study testing Virtual reality cognitive function training and Virtual scene intervention in people with Cerebral Small Vessel Disease and Postoperative Cognitive Function, run by Peking University Third Hospital at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhengqian Li, Associate Chief Physician (+86 156 1190 8458, zhengqianli@hsc.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07370844, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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