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The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery

The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05523258
Enrollment
174
Registered
2022-08-31
Start date
2022-09-01
Completion date
2024-12-31
Last updated
2022-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Cognitive Dysfunction(POCD)

Keywords

POCD, cardiac surgery, cognitive training

Brief summary

Whether enough time and high-quality cognitive training will reduce the incidence of postoperative cognitive dysfunction after cardiac surgery.

Detailed description

Firstly, after patients are admitted, the researchers will visit every patient, introduce the study protocol, the risks and rights of the subjects to them in detail, and obtain their signed informed consent. Then, researches will collect the baseline data of the patients and complete the baseline status data measurement, including cognitive function, sleep quality, anxiety and depression scores, multi-channel EEG recorder monitoring and functional magnetic resonance examination. According to the results of randomization, the intervention will be carried out according to the study protocol. The day before the operation, EEG cortical network connection status, cognitive function, sleep quality, anxiety and depression scores will be measured after the intervention to understand the effect of preoperative intervention on brain function. On the day of operation, anesthesia and operation will be performed according to clinical routine. And the multi-channel EEG will be detected after induction of anesthesia and during the period of sedation and recovery.When the patient meets the appropriate conditions, cognitive function training will be started as soon as possible. Researches will evaluate the patients' sleep quality and the incidence of delirium in the first six days after the operation. They will also evaluate cognitive function, sleep quality, anxiety and depression scores, and conduct postoperative delirium evaluation, multi-channel EEG recorder monitoring, functional magnetic resonance examination on the seventh day after operation.The cognitive function, sleep quality, anxiety and depression scores will be measured 30 days after operation. The Clinical Research Institute of Peking University undertakes the work of data collection and analysis of this project. A electronic data acquisition system based on network is used for data acquisition, where researchers need to input the research data accurately, timely and comprehensively. The audit and quality control will be fed back to the researchers in time. The researchers need to check the feedback one by one and record the check results in detail.

Interventions

BEHAVIORALComputerized cognition training

The researchers distribute tablet computers for the patients. The patients in this group receive cognitive function training under the guidance of a full-time cognitive function trainer. The training time is about 45-60 minutes every time, and the frequency is twice a day until the operation. After the operation, cognitive function training should be started as soon as possible when the patient meets the following conditions including Glasgow score ≥ 12, no mechanical ventilation and no sedative drugs. The training intensity is the same as that before operation, generally starting from the 2nd to 3rd day after operation and continuing to discharge or the 7th day after operation.

BEHAVIORALBasic training based on tablet computer

The researchers distribute the same tablet computer to the patients. The patients in this group receive basic training under the guidance of a full-time cognitive function trainer. The training duration is the same as that of the test group.

Sponsors

Mu Dong Liang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Agree to participate in this study voluntarily; * Age ≥ 60 years old; * Patients who intend to accept elective coronary artery bypass grafting or valve replacement; * The preoperative hospital stay is expected to be 5 days or more.

Exclusion criteria

* Definite diagnosis of senile dementia and Montreal Cognitive Assessment(MoCA) score ≤ 18; * Patients with severe visual or hearing impairment who cannot complete the cognitive function assessment; * Patients with limb movement disorder who cannot complete the cognitive function assessment; * Patients with claustrophobia who cannot complete functional magnetic resonance imaging(fMRI) examination; * The expected survival time is less than 1 month; * Patients within 3 months or participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative 7-day cognitive dysfunctionThe 7th day after operation

Secondary

MeasureTime frame
Postoperative 7-day changes of cortical network connectivity functionThe 7th day after operation
Postoperative 7-day changes of sleep qualityThe 7th day after operation
Postoperative 7-day changes of cognitive scoresThe 7th day after operation
Incidence of postoperative 30-day cognitive dysfunctionThe 30th day after operation
Postoperative 30-day main complications and mortalityThe 30th day after operation
Incidence of postoperative delirium within 7 daysWithin 7 days after operation

Contacts

Primary ContactDongliang Mu, Associate professor
mudongliang@bjmu.edu.cn13810702725

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026