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Stroke, Acute IschemicNCT05648149

Effect of Preventive Cognitive Training on Cognitive Impairment After Stroke in Acute Stage

A study testing hierarchical multi-dimensional cognitive training scheme based on computer in people with Stroke, Acute Ischemic and Cognitive Impairment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Stroke, Acute Ischemic, Cognitive Impairment
What is being tested?
hierarchical multi-dimensional cognitive training scheme based on computer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
No sites listed yet
Study dates
1 Jan 2023to 31 Dec 2023
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 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

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.

Read more

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.

Being tested
hierarchical multi-dimensional cognitive training scheme based on computer
Keywords
Post-stroke cognitive impairment, stroke, cognitive training, acute stage
Medical subject headings
Ischemic Stroke, Cognitive Dysfunction, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • hierarchical multi-dimensional cognitive training scheme based on computerBehavioural

    The scheme was constructed five main categories of cognitive function: (1) attention, memory, numeracy, thinking response and perception; (2) There are 10 training items, which are drawing, quick matching, flash memory, number memory, face memory, color tracking, number span, word naming, symbol number form, quick arithmetic; (3) Each training item is divided into basic and advanced training. Only if the basic training reaches more than 80%, can the advanced training be entered; (4) In order to facilitate patient training, all items were embedded in the wechat mini program, and corresponding cognitive training was carried out in the mini program; (5)Small program background can monitor training results.

Study groups in NCT05648149
Study groupRoleWhat they receive
hierarchical multi-dimensional cognitive training scheme based on computerExperimentalCognitive training was carried out by three trained and certified nurses in accordance with the cognitive training program. Twice a day, 30min each time, for 4 weeks, the difficulty of the training content is divided into 2 levels, the correct rate of more than 80% can enter the next level. During hospitalization, the patients and their families were taught how to use cognitive training programs. After discharge, special personnel were assigned to supervise and urge the patients to carry out cognitive training through the background.
Receives: Behavioral: hierarchical multi-dimensional cognitive training scheme based on computer
routine rehabilitationNo interventionRoutine treatment, rehabilitation and care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Cognitive Assessment

    An assessment tool for rapid screening of cognitive impairment. The total score is 30 points, and the test result shows that the normal value is ≥26 points.

    Measured: 0 week

  2. Montreal Cognitive Assessment

    An assessment tool for rapid screening of cognitive impairment. The total score is 30 points, and the test result shows that the normal value is ≥26 points.

    Measured: 1 week

  3. Montreal Cognitive Assessment

    An assessment tool for rapid screening of cognitive impairment. The total score is 30 points, and the test result shows that the normal value is ≥26 points.

    Measured: 12 week

  4. Montreal Cognitive Assessment

    An assessment tool for rapid screening of cognitive impairment. The total score is 30 points, and the test result shows that the normal value is ≥26 points.

    Measured: 24 week

  5. Mini-mental State Examination

    n assessment tool for reflect the mental state and the degree of cognitive impairment of the subjects. The total score range of 0-30 points. Scores are closely related to the level of education, and the normal cut-off is defined as: >17 points for illiteracy, >20 points for primary school, and >24 points for junior high school and above.

    Measured: 0 week

  6. Mini-mental State Examination

    n assessment tool for reflect the mental state and the degree of cognitive impairment of the subjects. The total score range of 0-30 points. Scores are closely related to the level of education, and the normal cut-off is defined as: >17 points for illiteracy, >20 points for primary school, and >24 points for junior high school and above.

    Measured: 1 week

  7. Mini-mental State Examination

    n assessment tool for reflect the mental state and the degree of cognitive impairment of the subjects. The total score range of 0-30 points. Scores are closely related to the level of education, and the normal cut-off is defined as: >17 points for illiteracy, >20 points for primary school, and >24 points for junior high school and above.

    Measured: 12 week

  8. Mini-mental State Examination

    n assessment tool for reflect the mental state and the degree of cognitive impairment of the subjects. The total score range of 0-30 points. Scores are closely related to the level of education, and the normal cut-off is defined as: >17 points for illiteracy, >20 points for primary school, and >24 points for junior high school and above.

    Measured: 24 week

  9. PSCI Incidence

    number of PSCI cases/total number of enrolled cases

    Measured: 12 weeks

  10. PSCI Incidence

    number of PSCI cases/total number of enrolled cases

    Measured: 24 weeks

Secondary outcomes (16)
  1. Hamilton Depression Scale

    An assessment tool for assessing depression status. Total score <7: normal; The total score of 7 to 17: depression may be present; The total score of 17 to 24: definitely depression; Total score >24: severe depression.

    Measured: 0 week

  2. Hamilton Depression Scale

    An assessment tool for assessing depression status. Total score <7: normal; The total score of 7 to 17: depression may be present; The total score of 17 to 24: definitely depression; Total score >24: severe depression.

    Measured: 1 week

  3. Hamilton Depression Scale

    An assessment tool for assessing depression status. Total score <7: normal; The total score of 7 to 17: depression may be present; The total score of 17 to 24: definitely depression; Total score >24: severe depression.

    Measured: 12 week

  4. Hamilton Depression Scale

    An assessment tool for assessing depression status. Total score <7: normal; The total score of 7 to 17: depression may be present; The total score of 17 to 24: definitely depression; Total score >24: severe depression.

    Measured: 24 week

  5. Hamilton Anxiety Scale

    It is mainly used to assess the severity of neurosis and anxiety symptoms in people. A total score of more than 29 may indicate severe anxiety; More than 21 points, there must be significant anxiety; More than 14 points, there is definitely anxiety; More than 7 points, may have anxiety; If the score is less than 7, there are no symptoms of anxiety.

    Measured: 0 week

  6. Hamilton Anxiety Scale

    It is mainly used to assess the severity of neurosis and anxiety symptoms in people. A total score of more than 29 may indicate severe anxiety; More than 21 points, there must be significant anxiety; More than 14 points, there is definitely anxiety; More than 7 points, may have anxiety; If the score is less than 7, there are no symptoms of anxiety.

    Measured: 1 week

  7. Hamilton Anxiety Scale

    It is mainly used to assess the severity of neurosis and anxiety symptoms in people. A total score of more than 29 may indicate severe anxiety; More than 21 points, there must be significant anxiety; More than 14 points, there is definitely anxiety; More than 7 points, may have anxiety; If the score is less than 7, there are no symptoms of anxiety.

    Measured: 12 week

  8. Hamilton Anxiety Scale

    It is mainly used to assess the severity of neurosis and anxiety symptoms in people. A total score of more than 29 may indicate severe anxiety; More than 21 points, there must be significant anxiety; More than 14 points, there is definitely anxiety; More than 7 points, may have anxiety; If the score is less than 7, there are no symptoms of anxiety.

    Measured: 24 week

  9. Modified Barthel index

    The scale consists of 10 items and 5 different weights of rating scales: unable, attempts but unsafe, moderate help, minimal help, fully independent. There is a score range of 0 to 5 for bathing, grooming; a score range of 0 to 10 for feeding, dressing, bowels, bladder, toilet, stairs; and a score range of 0 to 15 for chair/bed transfers, walking. Higher score represents higher degree of activities daily living independence.

    Measured: 0 week

  10. Modified Barthel index

    The scale consists of 10 items and 5 different weights of rating scales: unable, attempts but unsafe, moderate help, minimal help, fully independent. There is a score range of 0 to 5 for bathing, grooming; a score range of 0 to 10 for feeding, dressing, bowels, bladder, toilet, stairs; and a score range of 0 to 15 for chair/bed transfers, walking. Higher score represents higher degree of activities daily living independence.

    Measured: 1 week

  11. Modified Barthel index

    The scale consists of 10 items and 5 different weights of rating scales: unable, attempts but unsafe, moderate help, minimal help, fully independent. There is a score range of 0 to 5 for bathing, grooming; a score range of 0 to 10 for feeding, dressing, bowels, bladder, toilet, stairs; and a score range of 0 to 15 for chair/bed transfers, walking. Higher score represents higher degree of activities daily living independence.

    Measured: 12 week

  12. Modified Barthel index

    The scale consists of 10 items and 5 different weights of rating scales: unable, attempts but unsafe, moderate help, minimal help, fully independent. There is a score range of 0 to 5 for bathing, grooming; a score range of 0 to 10 for feeding, dressing, bowels, bladder, toilet, stairs; and a score range of 0 to 15 for chair/bed transfers, walking. Higher score represents higher degree of activities daily living independence.

    Measured: 24 week

  13. National Institutes of Health Neurological Deficit Score

    The scale will assess the degree of the neurological deficit. For all 11 parameters, the top score is 42 points, a score of 0 and 1 is normal, and higher scores mean a worse neurological deficit. We also recorded the neurological deficit result within two days after admission.

    Measured: 0 week

  14. National Institutes of Health Neurological Deficit Score

    The scale will assess the degree of the neurological deficit. For all 11 parameters, the top score is 42 points, a score of 0 and 1 is normal, and higher scores mean a worse neurological deficit. We also recorded the neurological deficit result within two days after admission.

    Measured: 1 week

  15. National Institutes of Health Neurological Deficit Score

    The scale will assess the degree of the neurological deficit. For all 11 parameters, the top score is 42 points, a score of 0 and 1 is normal, and higher scores mean a worse neurological deficit. We also recorded the neurological deficit result within two days after admission.

    Measured: 12 week

  16. National Institutes of Health Neurological Deficit Score

    The scale will assess the degree of the neurological deficit. For all 11 parameters, the top score is 42 points, a score of 0 and 1 is normal, and higher scores mean a worse neurological deficit. We also recorded the neurological deficit result within two days after admission.

    Measured: 24 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05648149
Sponsor's protocol ID
2023KY757
Status last verified
Jul 2022
First submitted
23 Nov 2022
Last updated
13 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing hierarchical multi-dimensional cognitive training scheme based on computer in people with Stroke, Acute Ischemic and Cognitive Impairment, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

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 5 inclusion and 4 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 13 Dec 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal Cognitive Assessment (time frame: 0 week). The study lists 10 primary outcomes in all. 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 13 Dec 2022.

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