Ischemic Stroke, Post-stroke Cognitive Impairment
Conditions
Keywords
Post-stroke Cognitive Impairment, Repetitive transcranial magnetic stimulation, High-frequency, Cerebellar
Brief summary
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.
Detailed description
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.
Interventions
DEVICEiTBS group
iTBS on the contralesional cerebellum, twice a day for seven days
DEVICEcontrol group
shame stimulation on the contralesional cerebellum, twice a day for seven days
Sponsors
Zi-Xiao Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter Randomized Double-Blind Controlled Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of improving cognitive function of post-stroke cognitive impairment | 3 months follow-up after treatment | The change of MoCA between baseline and 3 months follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The safety of improving cognitive function of post-stroke cognitive impairment | day1-day7 | Incidence of epilepsy during treatment |
Countries
China
Contacts
Primary ContactWeili Jia, Dr.
Outcome results
None listed