Atrial Fibrillation Follow-up Investigation to Recover Memory and learnING Trial

NCT ID: NCT05374642

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-19
• Study Completion Date: 2024-03-27

Brief Summary

The objective of the study is to evaluate the effectiveness of cognitive training in people with atrial fibrillation and cognitive decline over 12-week cognitive training. Moreover, the investigators will explore whether the training effect can be maintained.

Detailed Description

Introduction: Cognitive impairment is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia.The prevalence of dementia among people over 65 years old in China is 5.14% , while the prevalence of mild cognitive impairment is 20.8%. The risk of cognitive impairment and dementia in patients with atrial fibrillation is significantly higher than that those in the same age group, even after adjusted stroke and other common risk factors such as hypertension and diabetes. At present, the effectiveness of cognitive training in patients with atrial fibrillation complicated with cognitive impairment is not clear.

Objectives: The objective of the study is to evaluate whether cognitive training could lead cognitive improvement in patients with cognitive impairment and atrial fibrillation.

Patients and Methods: The proposed study is a double blinded, randomized and controlled trial that will include 200 patients with cognitive impairment and atrial fibrillation. The groups will be randomized to either intervention or active-control group. Both groups will receive computerized cognitive training performed for 30 minutes x 5 times/week over 12 weeks. A neuropsychological assessment will be administered at baseline and week 12 and 24 after the intervention. The structural and functional MRI will be performed at baseline and week 12 after intervention for a sub-study on the effect of cognitive training on brain structure and function.

Conditions

Cognitive Impairment; Atrial Fibrillation

Study Design

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

Study Groups

cognitive training

Group Type: EXPERIMENTAL

cognitive training

Intervention Type: BEHAVIORAL

tablet-based cognitive training for 12 weeks, 30 minutes each time, at least 5 times a week

active control

Group Type: ACTIVE_COMPARATOR

active control

Intervention Type: BEHAVIORAL

tablet-based cognitive training tasks with weak or no difficulty changes, 5 times a week, 30 minutes each time for 12 weeks

Interventions

cognitive training

tablet-based cognitive training for 12 weeks, 30 minutes each time, at least 5 times a week

Intervention Type: BEHAVIORAL

active control

tablet-based cognitive training tasks with weak or no difficulty changes, 5 times a week, 30 minutes each time for 12 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Older than 18 years;

2. Completion of 6 or more years of education;

3. Atrial fibrillation confirmed by ECG ;

4. Complain of memory decline within 1 year;

5. The score of any cognitive domain in the processing speed, episodic memory, working memory, and visual-spatial tested by the Basic Cognitive Ability Assessment (BCAT) is 1SD less than the average of the normal population;

6. Agree to receive cognitive function testing and randomization, be able to receive follow-up as required

Exclusion Criteria

1. Unable to complete the test due to vision, hearing and other problems;

2. Dementia or MMSE Scale ≤ 20;

3. Alcohol abuse or taking drugs that affect cognitive function (antihistamines, antipsychotics);

4. Cannot master the method of cognitive training tool after 2 times, 1 hour each time training instruction;

5. Planned atrial fibrillation ablation within 3 months or received ablation in the last 3 months;

6. CHA2DS2-VASc score ≥ 2 (for female ≥ 3), but refuses anticoagulation or has anticoagulation contraindications;

7. General anaesthesia in the last 3 months;

8. A history of stroke and head injury in the last 6 months;

9. Past history of Parkinson's disease, schizophrenia, and epilepsy;

10. Previous neurosurgery or a history of head tumor;

11. Contraindications for MRI examination: such as metal implantation, claustrophobia, etc.;

12. No family members to assist the patients to do the training course

• Minimum Eligible Age: 18 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

Chang sheng Ma

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Jia J, Zhou A, Wei C, Jia X, Wang F, Li F, Wu X, Mok V, Gauthier S, Tang M, Chu L, Zhou Y, Zhou C, Cui Y, Wang Q, Wang W, Yin P, Hu N, Zuo X, Song H, Qin W, Wu L, Li D, Jia L, Song J, Han Y, Xing Y, Yang P, Li Y, Qiao Y, Tang Y, Lv J, Dong X. The prevalence of mild cognitive impairment and its etiological subtypes in elderly Chinese. Alzheimers Dement. 2014 Jul;10(4):439-447. doi: 10.1016/j.jalz.2013.09.008. Epub 2014 Jan 10.

Reference Type: BACKGROUND

PMID: 24418053 (View on PubMed)

de Bruijn RF, Heeringa J, Wolters FJ, Franco OH, Stricker BH, Hofman A, Koudstaal PJ, Ikram MA. Association Between Atrial Fibrillation and Dementia in the General Population. JAMA Neurol. 2015 Nov;72(11):1288-94. doi: 10.1001/jamaneurol.2015.2161.

Reference Type: BACKGROUND

PMID: 26389654 (View on PubMed)

Chen LY, Norby FL, Gottesman RF, Mosley TH, Soliman EZ, Agarwal SK, Loehr LR, Folsom AR, Coresh J, Alonso A. Association of Atrial Fibrillation With Cognitive Decline and Dementia Over 20 Years: The ARIC-NCS (Atherosclerosis Risk in Communities Neurocognitive Study). J Am Heart Assoc. 2018 Mar 7;7(6):e007301. doi: 10.1161/JAHA.117.007301.

Reference Type: BACKGROUND

PMID: 29514809 (View on PubMed)

Sherman DS, Mauser J, Nuno M, Sherzai D. The Efficacy of Cognitive Intervention in Mild Cognitive Impairment (MCI): a Meta-Analysis of Outcomes on Neuropsychological Measures. Neuropsychol Rev. 2017 Dec;27(4):440-484. doi: 10.1007/s11065-017-9363-3. Epub 2017 Dec 27.

Reference Type: BACKGROUND

PMID: 29282641 (View on PubMed)

Other Identifiers

2022-AFFIRMING

Identifier Type: -

Identifier Source: org_study_id