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RECRUITINGINTERVENTIONAL

pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke

Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy Targeting at the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke: a RCT

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus (IFG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients between the ages of 35 and 75 years (including 35 and 75 years). - Meet the diagnostic criteria of acute ischemic stroke (using the 2019 American Heart Association/American Stroke Association Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke and the 2018 Chinese Society of Neurology Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). All lesions should be in the left hemisphere, and the course of disease should be more than or equal to 15 days and less than or equal to 3 months . - Meet the diagnostic criteria for aphasia according to the Chinese version of the Western Aphasia Battery (WAB), with a WAB-aphasia quotient less than 93.8. - First onset stroke. - Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school (more than 6 years' education). - Understand the trial and be able to provide willing to sign a consent form. Who Should NOT Join This Trial: - Combined severe dysarthria (NIHSS item 10 score ≥ 2 points); - Aphasia caused by bilateral hemispheric stroke, brain tumors, traumatic brain injury, Parkinson's disease, motor neuron disease, or other diseases; - Patients with implanted electronic devices such as cardiac pacemakers, cochlear implants, or other metal foreign bodies, or those with MRI contraindications such as claustrophobia or TMS treatment contraindications; - History of epilepsy; - Patients with severe systemic diseases such as heart, lung, liver, kidney diseases, etc., which cannot be controlled by routine medications as confirmed by laboratory tests and examinations; - Impaired consciousness (NIHSS item 1(a) score ≥ 1 point); - Malignant hypertension; - Malignant tumor; - Patients with a life expectancy of less than 1 year due to reasons other than stroke; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients between the ages of 35 and 75 years (including 35 and 75 years). * Meet the diagnostic criteria of acute ischemic stroke (using the 2019 American Heart Association/American Stroke Association Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke and the 2018 Chinese Society of Neurology Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China). All lesions should be in the left hemisphere, and the course of disease should be more than or equal to 15 days and less than or equal to 3 months . * Meet the diagnostic criteria for aphasia according to the Chinese version of the Western Aphasia Battery (WAB), with a WAB-aphasia quotient less than 93.8. * First onset stroke. * Normal functioning language abilities before the stroke, with Mandarin as their native language and an educational level higher than primary school (more than 6 years' education). * Understand the trial and be able to provide informed consent. Exclusion Criteria: * Combined severe dysarthria (NIHSS item 10 score ≥ 2 points); * Aphasia caused by bilateral hemispheric stroke, brain tumors, traumatic brain injury, Parkinson's disease, motor neuron disease, or other diseases; * Patients with implanted electronic devices such as cardiac pacemakers, cochlear implants, or other metal foreign bodies, or those with MRI contraindications such as claustrophobia or TMS treatment contraindications; * History of epilepsy; * Patients with severe systemic diseases such as heart, lung, liver, kidney diseases, etc., which cannot be controlled by routine medications as confirmed by laboratory tests and examinations; * Impaired consciousness (NIHSS item 1(a) score ≥ 1 point); * Malignant hypertension; * Malignant tumor; * Patients with a life expectancy of less than 1 year due to reasons other than stroke; * Severe hearing, visual, or cognitive impairments that prevent the patient from completing the trial; * Patients with severe depression, anxiety, or other mental illnesses that prevent them from completing the trial; * Patients who have received other neuroregulatory treatments such as TMS or transcranial electrical stimulation within 3 months before enrollment; * History of alcohol abuse, drug abuse, or other substance abuse; * Patients with other abnormal test results that make them unsuitable for participating in this trial as determined by the researchers; * Women of childbearing age who are pregnant or planning to become pregnant; * Patients participating in other clinical trials.

Treatments Being Tested

DEVICE

active continuous Theta Burst Stimulation

Each patient will receive two 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive days each week.

DEVICE

sham continuous Theta Burst Stimulation

Each patient will receive two sham 600-pulse cTBS stimulations per day, parted by a 15-minute rest period (a total of 1200 pulses daily), for 3-week treatment, with 5 consecutive days each week.

Locations (1)

First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China