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The objective of this clinical trial is to investigate the effectiveness and safety of repetitive transcranial magnetic stimulation (rTMS) in the cerebellum for individuals with post-stroke cognitive impairment. Participants will undergo rTMS in the cerebellar hemisphere opposite the lesion site, once daily for a total of five days.
The primary objective of this clinical trial is to investigate the effectiveness and safety of intermittent theta burst stimulation ( iTBS) in the cerebellum for individuals with post-stroke cognitive impairment. The trial aims to answer two main questions: (1) What is the effectiveness of iTBS in improving post-stroke cognitive impairment? (2) Is iTBS in the cerebellum safe for individuals with post-stroke cognitive impairment? Participants will undergo iTBS in the cerebellar opposite the lesion site, twice daily for five days. The control group will receive sham rTMS with the same parameters and positions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iTBS group | Experimental | iTBS on the contralesional cerebellum |
|
| control group | Placebo Comparator | shame stimulation on the contralesional cerebellum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTBS group | Device | iTBS on the contralesional cerebellum, twice a day for seven days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of improving cognitive function of post-stroke cognitive impairment | The change of MoCA between baseline and 3 months follow-up | 3 months follow-up after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of improving cognitive function of post-stroke cognitive impairment | Incidence of epilepsy during treatment | day1-day7 |
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Key inclusion criteria:
(1)ischemic stroke, with an initial incident occurring within 2 weeks;(2)MoCA<26;
Key exclusion criteria:
(1)Cerebral hemorrhage or subarachnoid hemorrhage;(2)A pre-existing history of epilepsy;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Jia, Dr. | Contact | +86 13120207987 | jiawl1994@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zixiao LI, Dr. | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan hospital | Recruiting | Beijing | 100070 | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Multicenter Randomized Double-Blind Controlled Study
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| control group |
| Device |
shame stimulation on the contralesional cerebellum, twice a day for seven days |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008722 | Methods |