Postoperative Cognitive Dysfunction(POCD)NCT05523258
The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery
A study testing Computerized cognition training and Basic training based on tablet computer in people with Postoperative Cognitive Dysfunction(POCD), run by Mu Dong Liang.
Trial summary
Whether enough time and high-quality cognitive training will reduce the incidence of postoperative cognitive dysfunction after cardiac surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction(POCD)
- What is being tested?
- Computerized cognition training and Basic training based on tablet computer
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Whether enough time and high-quality cognitive training will reduce the incidence of postoperative cognitive dysfunction after cardiac surgery.
Read the 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.
- Being tested
- Computerized cognition training, Basic training based on tablet computer
- Keywords
- POCD, cardiac surgery, cognitive training
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognition trainingBehavioural
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.
Basic training based on tablet computerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Computerized cognition training |
| Control group | Sham comparator | 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. Receives: Behavioral: Basic training based on tablet computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative 7-day cognitive dysfunction
Measured: The 7th day after operation
Secondary outcomes (6)
Postoperative 7-day changes of cognitive scores
Measured: The 7th day after operation
Postoperative 7-day changes of cortical network connectivity function
Measured: The 7th day after operation
Postoperative 7-day changes of sleep quality
Measured: The 7th day after operation
Incidence of postoperative delirium within 7 days
Measured: Within 7 days after operation
Incidence of postoperative 30-day cognitive dysfunction
Measured: The 30th day after operation
Postoperative 30-day main complications and mortality
Measured: The 30th day after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive Dysfunction(POCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mu Dong Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mu Dong Liang, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523258
- Sponsor's protocol ID
- 2022-156
- Status last verified
- Aug 2022
- First submitted
- 28 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Mechanism of Computerized Cognition Training on the Incidence of Postoperative Cognitive Dysfunction After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05523258
- Acronym / sponsor ID
- 2022-156
- Keywords
- POCD, cardiac surgery, cognitive training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Mu Dong LiangUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Computerized cognition trainingPatients 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. |
| Control group | Sham comparator | Behavioral: Basic training based on tablet computerPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized cognition trainingThe 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. | Behavioural | Intervention Group |
| Basic training based on tablet computerThe 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. | Behavioural | Control group |
Primary outcome
Incidence of postoperative 7-day cognitive dysfunction
Time frame: The 7th day after operation
6 secondary outcomes
Postoperative 7-day changes of cognitive scores
Time frame: The 7th day after operation
Postoperative 7-day changes of cortical network connectivity function
Time frame: The 7th day after operation
Postoperative 7-day changes of sleep quality
Time frame: The 7th day after operation
Incidence of postoperative delirium within 7 days
Time frame: Within 7 days after operation
Incidence of postoperative 30-day cognitive dysfunction
Time frame: The 30th day after operation
Postoperative 30-day main complications and mortality
Time frame: The 30th day after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognition training and Basic training based on tablet computer in people with Postoperative Cognitive Dysfunction(POCD), run by Mu Dong Liang.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dongliang Mu, Associate professor (13810702725, mudongliang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative 7-day cognitive dysfunction (time frame: The 7th day after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2022.