Phase
Condition
Stroke
Cerebral Ischemia
Communication Disorders
Treatment
active 2400-pulse continuous Theta Burst Stimulation
active 1200-pulse continuous Theta Burst Stimulation
active 3600-pulse continuous Theta Burst Stimulation
Clinical Study ID
Ages 35-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient's age ranges from 35 to 75 years old (including 35 and 75 years old);
Meet the diagnostic criteria for ischemic stroke (according to the guidelinesdeveloped by the American Heart Association/American Stroke Association in 2019 andthe guidelines developed by the Neurology Branch of the Chinese Medical Associationin 2018) or meet the diagnostic criteria for hemorrhagic stroke (according to theguidelines developed by the American Heart Association/American Stroke Associationin 2022 and the guidelines developed by the Neurology Branch of the Chinese MedicalAssociation in 2019) ,with lesions located in the left hemisphere, and a duration ofillness ranging from 15 days to 6 months.
Diagnosed as aphasia patient according to the Chinese version of Western AphasiaBattery (WAB), with a WAB-aphasia quotient of less than 93.8 points;
First onset of stroke;
Normal language function before the onset of stroke, and the patient's nativelanguage is Chinese with at least 6 years of education;
Understand the trial and signed the informed consent form.
Exclusion
Exclusion Criteria:
Combined dysarthria (NIHSS item 10 score ≥2 points);
Aphasia caused by bilateral hemisphere stroke, brain tumor, traumatic brain injury,Parkinson's disease, motor neuron disease, or other diseases;
Patients with implanted electronic devices such as cardiac pacemakers, cochlearimplants, or other metal foreign bodies, or those with MRI contraindications such asclaustrophobia or TMS treatment contraindications;
History of epilepsy;
Patient with concomitant severe systemic diseases affecting the heart, lungs, liver,kidneys, etc., and uncontrolled by conventional medication, as detected andconfirmed through laboratory testing and examination;
Patients with consciousness disorders (NIHSS 1(a) score ≥1);
Patients with malignant hypertension;
Patients with severe organic diseases, such as malignant tumors, with an expectedsurvival time of less than 1 year;
Patients with severe hearing, visual, cognitive impairment or inability to cooperatewith the trial;
Patients with severe depression, anxiety, or diagnosed with other mental illnessesthat prevent them from completing the trial;
Patients who have received other neuromodulation treatments such as TMS,transcranial electric stimulation, etc. in the 3 months prior to enrollment;
Patients with a history of alcoholism, drug abuse, or other substance abuse;
Patients with other abnormal findings that the researchers judge are not suitablefor participation in this trial;
Patients who are unable to complete follow-up due to geographical or other reasons;
Women of childbearing age who are currently pregnant, breastfeeding, or planning ormay become pregnant during the trial;
Patients who are currently participating in other clinical trials.
Study Design
Study Description
Connect with a study center
Nanshi Hospital of Nanyang
Nanyang, Henan
ChinaActive - Recruiting
The fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaActive - Recruiting
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