Status:
COMPLETED
Atrial Fibrillation Follow-up Investigation to Recover Memory and learnING Trial
Lead Sponsor:
Beijing Anzhen Hospital
Collaborating Sponsors:
Beijing Wispirit Technology Co., Ltd
Conditions:
Cognitive Impairment
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 preval...
Eligibility Criteria
Inclusion
- Older than 18 years;
- Completion of 6 or more years of education;
- Atrial fibrillation confirmed by ECG ;
- Complain of memory decline within 1 year;
- 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;
- Agree to receive cognitive function testing and randomization, be able to receive follow-up as required
Exclusion
- Unable to complete the test due to vision, hearing and other problems;
- Dementia or MMSE Scale ≤ 20;
- Alcohol abuse or taking drugs that affect cognitive function (antihistamines, antipsychotics);
- Cannot master the method of cognitive training tool after 2 times, 1 hour each time training instruction;
- Planned atrial fibrillation ablation within 3 months or received ablation in the last 3 months;
- CHA2DS2-VASc score ≥ 2 (for female ≥ 3), but refuses anticoagulation or has anticoagulation contraindications;
- General anaesthesia in the last 3 months;
- A history of stroke and head injury in the last 6 months;
- Past history of Parkinson's disease, schizophrenia, and epilepsy;
- Previous neurosurgery or a history of head tumor;
- Contraindications for MRI examination: such as metal implantation, claustrophobia, etc.;
- No family members to assist the patients to do the training course
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05374642
Start Date
September 19 2022
End Date
March 27 2024
Last Update
May 24 2024
Active Locations (1)
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1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China