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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Cognitive Dysfunction(POCD)
• Intervention / Treatment: Behavioral: Computerized cognition training; Behavioral: Basic training based on tablet computer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dongliang Mu, Associate professor; Phone Number: 13810702725; Email: mudongliang@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; Patients in this group will receive computerized cognition training, including processing speed, attention, perception, long-term memory, working memory, calculation, executive control, reasoning and problem solving. The training program and its difficulty are constantly adjusted with the patients' training performance.	Behavioral: Computerized 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.
SHAM_COMPARATOR: Control group; Patients in this group will receive basic training based on tablet computer, and the subjects will receive five training tasks of processing speed and attention, which are fixed in difficulty and scheme. The training methods and intensity are similar to the intervention group.	Behavioral: Basic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative 7-day cognitive dysfunction	The 7th day after operation

Secondary Outcome Measures

Outcome Measure	Time Frame
Postoperative 7-day changes of cognitive scores	The 7th day after operation
Postoperative 7-day changes of cortical network connectivity function	The 7th day after operation
Postoperative 7-day changes of sleep quality	The 7th day after operation
Incidence of postoperative delirium within 7 days	Within 7 days after operation
Incidence of postoperative 30-day cognitive dysfunction	The 30th day after operation
Postoperative 30-day main complications and mortality	The 30th day after operation

Collaborators and Investigators

• Sponsor: Mu Dong Liang

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: August 28, 2022
• First Submitted That Met QC Criteria: August 28, 2022
• First Posted (ACTUAL): August 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: cardiac surgery; cognitive training; POCD
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: 2022-156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No