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| Name | Class |
|---|---|
| Xuanwu Hospital, Beijing | OTHER |
| Fu Xing Hospital, Capital Medical University | OTHER |
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This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with subcortical VCIND. Half of participants will receive multi-domain adaptive internet-based training program, while the other half will receive a fixed, primary difficulty level task.
Background:
Vascular cognitive impairment no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes which fall short of a dementia diagnosis. Because of its high prevalence and high progression to dementia, interest in VCIND has greatly expanded in recent years. Although it has been widely recognized that early intervention of VCIND holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Executive dysfunction is the characteristic impairment in subcortical VCIND, and cognitive training significantly improved executive and other aspects of cognitive function in health older adults and patients with cognitive impairment. Whether and how cognitive training improves cognitive function in patients with VCIND remains largely unknown.
Objectives:
The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive training in patients with subcortical VCIND improves their cognitive abilities. The second objective is to evaluate the effect of cognitive training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI. Finally, possible genetic and plasma biomarkers related to a positive effect or lack of effect of the training will be examined.
Patients and Methods:
The proposed study is a three-center, double-blinded, randomized controlled trial that will include 60 patients diagnosed with VCIND from the neurology clinics at Beijing Friendship hospital, Xuan Wu hospital, and geriatric clinic at Fu Xing hospital, Capital Medical University. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive training performed for 30 minutes over 35 sessions. Neuropsychological assessment and functional magnetic resonance imaging (MRI) will be performed before and 7 weeks after training.
Relevance:
Currently there is no known treatment available for VCIND. The proposed study is to determine the efficacy of cognitive training in patients with VCIND. Secondly, using functional and structural MRI, this study is to reveal the potential mechanism underlying cognitive training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| training group | Active Comparator | Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks. |
|
| control group | Placebo Comparator | Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multi-domain internet-based adaptive training program | Behavioral | The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Mean Change of the Montreal Cognitive Assessment (MoCA) | The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive training. Baseline and 7-week were the two relevant time points used in the calculation. The score of MoCA ranges from 0 to 30, and higher scores mean a better outcome. | Baseline and 7 weeks |
| Estimated Mean Change of the Trail Making Test (TMT) B-A | The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The change from baseline at week 7 in the B-A difference is reported as a primar | Baseline and 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Mean Changes in Left Hippocampal Volume | The left hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean changes in left hippocampal volume from baseline at week 7 is reported. | Baseline and 7 weeks |
| Estimated Mean Change in Right Hippocampal Volume |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Mean Change of MoCA | The participants will be followed up 6 months after recruitment. The training is not mandatory after 7 weeks, but the training details will be acquired from the online system. The change from baseline at month 6 in the MoCA difference is reported. The score of Moca ranges from 0 to 30, and higher scores mean a better outcome. | Baseline and 6 months |
Inclusion Criteria:
The MRI entry criteria are as follows:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yi Tang, M.D., Ph.D. | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100050 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38828650 | Derived | Li QG, Xing Y, Zhu ZD, Fei XL, Tang Y, Lu J. Effects of computerized cognitive training on functional brain networks in patients with vascular cognitive impairment and no dementia. CNS Neurosci Ther. 2024 Jun;30(6):e14779. doi: 10.1111/cns.14779. | |
| 27496126 | Derived | Tang Y, Zhu Z, Liu Q, Li F, Yang J, Li F, Xing Y, Jia J. The efficacy of Cognitive training in patients with VAsCular Cognitive Impairment, No dEmentia (the Cog-VACCINE study): study protocol for a randomized controlled trial. Trials. 2016 Aug 5;17(1):392. doi: 10.1186/s13063-016-1523-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Training Group | Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks. multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels. |
| FG001 | Control Group | Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks. placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Training Group | Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks. multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Estimated Mean Change of the Montreal Cognitive Assessment (MoCA) | The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive training. Baseline and 7-week were the two relevant time points used in the calculation. The score of MoCA ranges from 0 to 30, and higher scores mean a better outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 7 weeks |
|
7 weeks, 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Training Group | Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks. multi-domain internet-based adaptive training program: The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yi Tang | Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China | +86 10 83199456 | tangyi@xwhosp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 13, 2015 | Jan 13, 2020 | Prot_SAP_000.pdf |
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|
| placebo program | Behavioral | For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set. |
|
The right hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean change in right hippocampal volume from baseline at week 7 is reported. |
| Baseline and 7 weeks |
| Estimated Mean Change in Brain White Matter Integrity | The white matter microstructure was measured by diffusion tensor imaging (DTI) . The whole-brain average fractional anisotropy (FA) was calculated to show brain white matter integrity. The change of whole-brain average FA from baseline at week 7 is reported. Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. | Baseline and 7 weeks |
| BG001 | Control Group | Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks. placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for cognitive dysfunction. It is rated on a 30-point scale and assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The higher score represents a better cognitive function. | Mean | Standard Deviation | units on a scale |
|
| Trail Making Test B-A (TMT B-A) | The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). | Mean | Standard Deviation | second |
|
| OG001 | Control Group | Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks. placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set. |
|
|
| Primary | Estimated Mean Change of the Trail Making Test (TMT) B-A | The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The change from baseline at week 7 in the B-A difference is reported as a primar | Posted | Mean | 95% Confidence Interval | second | Baseline and 7 weeks |
|
|
|
| Secondary | Estimated Mean Changes in Left Hippocampal Volume | The left hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean changes in left hippocampal volume from baseline at week 7 is reported. | Posted | Mean | 95% Confidence Interval | Cubic millimeter | Baseline and 7 weeks |
|
|
|
| Secondary | Estimated Mean Change in Right Hippocampal Volume | The right hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean change in right hippocampal volume from baseline at week 7 is reported. | Posted | Mean | 95% Confidence Interval | Cubic millimeter | Baseline and 7 weeks |
|
|
|
| Secondary | Estimated Mean Change in Brain White Matter Integrity | The white matter microstructure was measured by diffusion tensor imaging (DTI) . The whole-brain average fractional anisotropy (FA) was calculated to show brain white matter integrity. The change of whole-brain average FA from baseline at week 7 is reported. Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 7 weeks |
|
|
|
| Other Pre-specified | Estimated Mean Change of MoCA | The participants will be followed up 6 months after recruitment. The training is not mandatory after 7 weeks, but the training details will be acquired from the online system. The change from baseline at month 6 in the MoCA difference is reported. The score of Moca ranges from 0 to 30, and higher scores mean a better outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 6 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control Group | Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks. placebo program: For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set. | 0 | 30 | 0 | 30 | 0 | 30 |
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