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The study has been registed in ChiCTR and apply for withdrawing.
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The goal of this clinical trial is to test the therapeutic effect of theta burst stimulation (TBS), which is one of stimulus pattern of repetitive transcranial magnetic stimulation, in patients with post stroke cognition impairment (PSCI). The main questions it aims to answer are:
Participants will be asked to do:
Researchers will compare high-dose group, low-dose group and sham group to see if TBS play a role in PSCI and if the effect of high dose TBS was stronger than low dose.
the procedure of study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high dose TBS group | Experimental | parameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz |
|
| low dose TBS group | Experimental | parameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz |
|
| high dose sham TBS group | Sham Comparator | parameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz |
|
| low dose sham TBS group | Sham Comparator | parameters: pattern: intermittent TBS (iTBS; 2 seconds of TBS are delivered every 10 seconds), TBS consists of pulses applied in bursts of 3 at 50 Hz with an interburst interval at 5 Hz |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| theta burst stimulation | Device | expect for the TBS, all patients get cognitive training alike on a training system in medical center. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Montreal Cognitive Assessment scale | one of the most used scales to assess cognition and screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level. | 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Mini-mental State Examination scale | Easy to use and one of the most used scales to screen person with cognitive impairment in the world. The minimum and maximum values range from 0 to 30. Higher score means better cognition level. | 1. finished in 3 days before TBS stimulation. 2. finished in 3 days after stimulation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hao Zhang | China Rehabilitation Research Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China rehabilitation research center | Beijing | Beijing Municipality | 100071 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| sham stimulation | Device | expect for the TBS, all patients get cognitive training alike on a training system in medical center. |
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |