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

Primary Purpose

Postoperative Cognitive Dysfunction(POCD)

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Computerized cognition training
Basic training based on tablet computer
Sponsored by
Mu Dong Liang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cognitive Dysfunction(POCD) focused on measuring POCD, cardiac surgery, cognitive training

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Intervention Group

    Control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Incidence of postoperative 7-day cognitive dysfunction

    Secondary Outcome Measures

    Postoperative 7-day changes of cognitive scores
    Postoperative 7-day changes of cortical network connectivity function
    Postoperative 7-day changes of sleep quality
    Incidence of postoperative delirium within 7 days
    Incidence of postoperative 30-day cognitive dysfunction
    Postoperative 30-day main complications and mortality

    Full Information

    First Posted
    August 28, 2022
    Last Updated
    August 31, 2022
    Sponsor
    Mu Dong Liang
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05523258
    Brief Title
    The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery
    Official Title
    The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mu Dong Liang

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Cognitive Dysfunction(POCD)
    Keywords
    POCD, cardiac surgery, cognitive training

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    174 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Computerized cognition training
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Basic training based on tablet computer
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of postoperative 7-day cognitive dysfunction
    Time Frame
    The 7th day after operation
    Secondary Outcome Measure Information:
    Title
    Postoperative 7-day changes of cognitive scores
    Time Frame
    The 7th day after operation
    Title
    Postoperative 7-day changes of cortical network connectivity function
    Time Frame
    The 7th day after operation
    Title
    Postoperative 7-day changes of sleep quality
    Time Frame
    The 7th day after operation
    Title
    Incidence of postoperative delirium within 7 days
    Time Frame
    Within 7 days after operation
    Title
    Incidence of postoperative 30-day cognitive dysfunction
    Time Frame
    The 30th day after operation
    Title
    Postoperative 30-day main complications and mortality
    Time Frame
    The 30th day after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dongliang Mu, Associate professor
    Phone
    13810702725
    Email
    mudongliang@bjmu.edu.cn

    12. IPD Sharing Statement

    Learn more about this trial

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

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