Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment

NCT ID: NCT05735041

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-18
• Study Completion Date: 2025-07-31

Brief Summary

In this study, a multicentre, double-blind, randomized controlled study based on cognitive training was conducted in patients with coronary heart disease and cognitive impairment but without dementia， to evaluate the effectiveness of computer-based digital therapy in improving the cognitive function of such patients.

Detailed Description

This study is a multicentre, double-blind, parallel randomized controlled study using a 1:1 parallel control design. A total of 200 patients with coronary heart disease combined with cognitive decline but no dementia were enrolled in 8 centres. These patients will be randomized to two arms under masking. The intervention arm will receive multi-domain adaptive cognitive training using a tablet. The control arm will receive an active control treatment and use the same tablet to receive the cognitive training tasks with weak difficulty change. Both arms will receive the same intervention dosage for 12 weeks, 5 times a week, and 30 minutes per time. After the 12-week intervention, the intervention arm will be re-randomized into two groups. One group will stop their intervention at 12 weeks; the other group will continue to receive the multi-domain adaptive cognitive training till the 24-week follow-up assessment. The neuro-psychological assessment will be administered at baseline, 12-week, and 24-week assessments for all participants. The structural and functional MRI will be administered at baseline, 12 weeks, and 24 weeks to evaluate the effect of cognitive training on brain structure and function.

Conditions

Mild Cognitive Impairment; Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cognitive digital therapy group

Computer-based cognitive training for 30 minutes at least 5 times a week for 12 weeks; At the end of the 12 weeks, the subjects were randomly divided into two groups. One group continued the training for 12 weeks, at least five times a week for 30 minutes each time, and the other group stopped the training.

Group Type: EXPERIMENTAL

Multi-domain cognitive digital therapy

Intervention Type: BEHAVIORAL

Patients in the cognitive digital therapy group received multi-dimensional targeted cognitive function training electronically, involving attention, memory, executive function, thinking, processing speed and perception. The system will adjust the training difficulty and training plan adaptively according to the patient's current training time and performance, and train the patient's weak cognitive ability as far as possible. The patients had the same total amount of training each day.

Positive control group

Computer-based cognitive training tasks with low or no difficulty variation for 30 minutes at least five times a week for 12 weeks

Group Type: ACTIVE_COMPARATOR

Basic cognitive therapy

Intervention Type: BEHAVIORAL

The training content of the positive control group was cognitive training tasks with weak difficulty or no difficulty change. The patients underwent cognitive function training with fixed programs, including 15 training items, and the internal difficulty of the training items remained constant without change. The system presents the training content randomly according to the training scheme. The patients had the same total amount of training each day.

Interventions

Multi-domain cognitive digital therapy

Patients in the cognitive digital therapy group received multi-dimensional targeted cognitive function training electronically, involving attention, memory, executive function, thinking, processing speed and perception. The system will adjust the training difficulty and training plan adaptively according to the patient's current training time and performance, and train the patient's weak cognitive ability as far as possible. The patients had the same total amount of training each day.

Intervention Type: BEHAVIORAL

Basic cognitive therapy

The training content of the positive control group was cognitive training tasks with weak difficulty or no difficulty change. The patients underwent cognitive function training with fixed programs, including 15 training items, and the internal difficulty of the training items remained constant without change. The system presents the training content randomly according to the training scheme. The patients had the same total amount of training each day.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Over the age of 50;

2. Completion of more than 6 years of education;

3. Patients with coronary artery disease confirmed by coronary CT angiography or coronary angiography;

4. Chief complaint of cognitive decline within 1 year;

5. The average score of any cognitive domain in processing speed, situational memory, working memory and visual space measured by the Basic Cognitive Ability Test (BCAT) is less than 1 SD compared with the normal population;

6. Agree to be randomized to cognitive function tests and cognitive training and be able to receive follow-up as required.

Exclusion Criteria

1. Previous definite diagnosis of dementia or brief Mental State Examination Scale (MMSE) < 24 points;

2. Cognitive dysfunction caused by cranial trauma, cranial tumor, Parkinson's disease, schizophrenia, Alzheimer's disease, anxiety and depression, and other neuropsychiatric diseases;

3. Deaf and mute or other reasons cannot communicate normally;

4. Binge drinking or taking drugs (antihistamines, antipsychotics) that affect cognitive function;

5. Unable to master the use of cognitive training equipment after two 1-hour training instructions each time;

6. Patients who plan to undergo coronary intervention within 6 months or have undergone coronary intervention within 1 month;

7. Severe liver and kidney function injury or critical condition, poor prognosis, estimated survival of less than 1 month.

8. Patients who had received general anesthesia within 3 months;

9. History of stroke and craniocerebral trauma within 6 months;

10. History of Parkinson's disease, schizophrenia, and epilepsy;

11. Prior neurosurgery or history of cranial tumors;

12. Nuclear magnetic examination contraindications: such as metal implants, claustrophobia, etc.;

13. patients living alone;

14. Patients with atrial fibrillation, structural heart disease, and infective endocarditis.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Wispirit Technology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong Zeng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Anzhen Hospital

Beijing, , China

Beijing Sixth Hospital

Beijing, , China

Peking University Third Hospital

Beijing, , China

The second hospital of Chifeng

Chifeng, , China

Handan Central Hospital

Handan, , China

Inner Mongolia Ordos Central Hospital Kangbashi Department

Ordos, , China

The First Affiliated Hospital of Hebei North University

Shijiazhuang, , China

The First Hospital of Hebei Medical University

Zhangjiakou, , China

Countries

China

References

Ye Y, Chen Q, Li R, Wang X, Sun Y, Li F, Liu X, Wang L, Ning X, Tian H, Zhao W, Ma C, Zhang H, Zeng Y. The efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol for a randomized controlled trial. Trials. 2025 Feb 21;26(1):64. doi: 10.1186/s13063-025-08745-6.

Reference Type: DERIVED

PMID: 39985041 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022BFAZ02

Identifier Type: -

Identifier Source: org_study_id