pBFS-guided cTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke
Personalized Brain Functional Sector-guided Continuous Theta Burst Stimulation Therapy Targeting at Superior Temporal Gyrus for Aphasia After Ischemic Stroke: a RCT
Changping Laboratory
40 participants
Nov 7, 2023
INTERVENTIONAL
Conditions
Summary
The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Superior Temporal Gyrus (STG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.
Eligibility
Inclusion Criteria6
- The patient's age ranges from 35 to 75 years old (including 35 and 75 years old);
- Meet the diagnostic criteria for acute ischemic stroke (diagnosed according to the "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" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, a duration of ≥15 days and ≤3 months;
- Diagnosed as aphasia patient according to the Chinese version of Western Aphasia Battery (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 native language is Chinese with at least 6 years of education;
- Understand the trial and signed the informed consent form.
Exclusion Criteria16
- Combined severe 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, cochlear implants, or other metal foreign bodies, or those with MRI contraindications such as claustrophobia 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 and confirmed 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 expected survival time of less than 1 year;
- Patients with severe hearing, visual, cognitive impairment or inability to cooperate with the trial;
- Patients with severe depression, anxiety, or diagnosed with other mental illnesses that 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 suitable for 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 or may become pregnant during the trial;
- Patients who are currently participating in other clinical trials.
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Interventions
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 workdays each week.
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 workdays each week.
Locations(2)
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NCT05999318