Clinical trial NCT05648149: Effect of Preventive Cognitive Training on Cognitive Impairment After Stroke in Acute Stage
Official title: Effect of Preventive Cognitive Training on Cognitive Impairment After Stroke in Acute Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Acute Ischemic
Cognitive Impairment
Keywords: Post-stroke cognitive impairment
stroke
cognitive training
acute stage
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-13
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Post-stroke cognitive impairment(PSCI) refers to a clinical syndrome characterized by cognitive impairment that occurs after a stroke event and persists for 6 months. PSCI is divided into post-stroke cognitive impairment non-dementia and post-stroke dementia. About one half of patients develop PSCI within the first year after stroke. Recent large international cohort studies have reported that the incidence of PSCI is 24%-53.4%, among which the incidence of cognitive impairment after stroke without dementia is 14%-29% and the incidence of dementia after stroke is 11%-42%. A study in China shows that the incidence of PSCI is 53.1%. Our previous small sample study also found that the incidence of cognitive impairment in acute phase of ischemic stroke patients was 64.52%. It can be seen that the incidence of PSCI is high, which is an important health problem.

The mortality rate of stroke patients complicated with PSCI is significantly higher than that of patients without cognitive impairment. The 5-year survival rate of patients with post-stroke dementia is only 39%, while the survival rate of stroke patients without dementia of the same age is 75%. In addition, patients with PSCI will lead to long-term disability, a significant decline in self-care ability of daily living, quality of life and mental health status, poor social participation ability, and increased care pressure. If not intervened in time, will bring serious disease and economic burden to the family and society. Therefore, preventing the occurrence and delaying the progression of PSCI is an important task to be solved urgently.

Rehabilitation is an important intervention to delay the progression of PSCI, aiming to promote the remodeling of the central nervous system, and the main method is early and multi-dimensional cognitive function training. Some studies have confirmed that computerization, multi-cognitive domains, and adaptive cognitive training (7 consecutive weeks, 5 days a week, 30 min a day) can significantly improve the global cognitive function of patients with cognitive impairment after subcortical stroke and non-dementia . A recent systematic review showed that cognitive training can improve the cognitive function and daily living ability of patients with mild PSCI. It also has a certain effect on the improvement of patients' overall cognitive function. It can be seen that cognitive training is not effective for all stages of PSCI patients, and the effect of cognitive training is very limited for patients who have developed into a single dimension of severe damage, serious overall cognitive impairment even dementia. This suggests that targeted cognitive intervention for patients at the acute stage of stroke may achieve the purpose of preventing the occurrence and delaying the progression of PSCI.

Therefore, this study innovatively proposed the concept of preventive cognitive training for patients with acute stroke. In the basis of literature research, combined with the views of the cognitive domain experts and Kang Fushi reformed the existing cognitive training plan, build the computer-assisted ladder multidimensional cognitive training scheme, the main dimensions set up on the basis of cognitive training program, according to the degree of cognitive impairment at the same time set the difficulty level of the project, It is convenient for medical staff to select appropriate items and difficulties based on the dimension and degree of cognitive impairment of patients. To evaluate the effect of cognitive training by using cognitive function scale, psycho-psychological scale, self-care ability scale and other tools, and to clarify whether acute preventive cognitive training can improve PSCI, so as to provide a practical basis for the prevention and intervention of PSCI.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed as ischemic stroke by CT or MRI and meeting World Health Organization diagnostic criteria First onset, within 7 days of onset

* There were no contraindications in MRI examination, and the examination was completed with good image quality and complete clinical data
* Between 18 and 64 years old
* Conscious (NIHSS consciousness level 0, 1)
* Informed consent.

Exclusion Criteria:

* Patients with previous cognitive impairment
* Aphasia or severe dysarthria
* Previous cerebral atrophy or white matter lesions
* History of severe cardiopulmonary dysfunction, craniocerebral trauma, etc

Primary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: 0 week
measure: Montreal Cognitive Assessment
timeFrame: 1 week
measure: Montreal Cognitive Assessment
timeFrame: 12 week
measure: Montreal Cognitive Assessment
timeFrame: 24 week
measure: Mini-mental State Examination
timeFrame: 0 week
measure: Mini-mental State Examination
timeFrame: 1 week
measure: Mini-mental State Examination
timeFrame: 12 week
measure: Mini-mental State Examination
timeFrame: 24 week
measure: PSCI Incidence
timeFrame: 12 weeks
measure: PSCI Incidence
timeFrame: 24 weeks
Secondary outcomes:
measure: Hamilton Depression Scale
timeFrame: 0 week
measure: Hamilton Depression Scale
timeFrame: 1 week
measure: Hamilton Depression Scale
timeFrame: 12 week
measure: Hamilton Depression Scale
timeFrame: 24 week
measure: Hamilton Anxiety Scale
timeFrame: 0 week
measure: Hamilton Anxiety Scale
timeFrame: 1 week
measure: Hamilton Anxiety Scale
timeFrame: 12 week
measure: Hamilton Anxiety Scale
timeFrame: 24 week
measure: Modified Barthel index
timeFrame: 0 week
measure: Modified Barthel index
timeFrame: 1 week
measure: Modified Barthel index
timeFrame: 12 week
measure: Modified Barthel index
timeFrame: 24 week
measure: National Institutes of Health Neurological Deficit Score
timeFrame: 0 week
measure: National Institutes of Health Neurological Deficit Score
timeFrame: 1 week
measure: National Institutes of Health Neurological Deficit Score
timeFrame: 12 week
measure: National Institutes of Health Neurological Deficit Score
timeFrame: 24 week
Other outcomes:
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