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Recruiting Not applicable NCT07546877

High-Frequency Repetitive Transcranial Magnetic Stimulation for Cognitive Improvement in Patients With Post-Stroke Cognitive Impairment

No applicable phase (e.g. observational)
Conditions: Post-Stroke Cognitive Impairment (PSCI) Repetitive Transcranial Magnetic Stimulation (rTMS) Stroke

Sponsor: Qilu Hospital of Shandong University

trial.available_in: БГ
Overview
To clarify the clinical efficacy of high-frequency rTMS on patients with post-stroke cognitive impairment, fNIRS and EEG techniques were used to observe the changes in brain functional activities of patients with post-stroke cognitive impairment after rTMS treatment, and to clarify the neuroregulatory effect of rTMS on patients with post-stroke cognitive impairment.
Description
The experimental group will receive rTMS stimulation therapy, which involves applying high-frequency 10Hz rTMS to the patient's head for 20 minutes, once a day, for a total of 20 sessions. The control group will undergo rTMS sham stimulation therapy, using a sham stimulation coil to apply the same parameters and method of stimulation to the head. Although the sham stimulation coil has no difference in appearance and sound from the real stimulation coil, it cannot generate a real magnetic field to stimulate the brain. You need to be evaluated before the treatment begins, after 10 sessions, and 20 sessions of the treatment. The evaluation content includes: Researchers will use relevant clinical evaluation scales to conduct functional evaluations on you, and perform near-infrared and electroencephalogram brain imaging measurements.
Who can participate
Inclusion Criteria: 1. Meets the diagnostic criteria for stroke as stipulated in the "Guidelines for the Prevention and Treatment of Stroke in China (2021 Edition)", and the initial stroke diagnosis is confirmed by cranial CT or MRI examination, and is confirmed as the initial onset; 2. The disease course is 1-12 months; 3. Has cognitive impairment (MoCA \< 26 points, education years ≤ 12 years, add 1 point to the score result); 4. Age 35-75 years old, gender not limited; 5. Stable vital signs, no progressive neurological symptoms; 6. No severe aphasia, visual or auditory impairment, and able to complete the research protocol; 7. Not using antidepressant drugs simultaneously; 8. If using cognitive-improving drugs (such as donepezil, memantine), it should last for at least 3 weeks or more, and no dose adjustment will be made during the enrollment period; 9. Voluntarily participate and sign the informed consent form. Exclusion Criteria: 1. Has a history of brain tumors, brain trauma, epilepsy or mental disorders; 2. Had cognitive impairment before the stroke; 3. Underwent craniotomy or had a skull defect; 4. Had implanted metal or electronic devices (such as cardiac pacemakers, cochlear implants, deep brain stimulators, aneurysm clips, internal fixation devices after ventriculoperitoneal shunt surgery, etc.); 5. Has other serious diseases that may affect the study; 6. Pregnant women
Interventions
sham repetitive transcranial magnetic stimulation
OTHER
repetitive transcranial magnetic stimulation
DEVICE
Locations 1
China (1)
Qilu Hospital of Shandong University
Jinan
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
35 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.07.2027
Registry ID
NCT07546877
Source
clinicaltrials.gov
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