RecruitingNot ApplicableNCT05957354

pBFS-guided Dual-target cTBS for Aphasia After Stroke

Personalized Brain Functional Sector-guided Dual-target Continuous Theta Burst Stimulation Therapy for Aphasia After Stroke: a RCT

Sponsor

Changping Laboratory

Enrollment

60 participants

Start Date

Jul 28, 2023

Study Type

INTERVENTIONAL

Conditions

Stroke Aphasia

Summary

The objective of this trial is to evaluate the effectiveness and safeness of personalized brain functional sectors (pBFS) technology-guided continuous theta burst stimulation (cTBS) on the inferior frontal gyrus (IFG) combined with the superior temporal gyrus (STG) for language function recovery in post-stroke aphasic patients.

Eligibility

Min Age: 35 YearsMax Age: 75 Years

Inclusion Criteria6

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 guidelines developed by the American Heart Association/American Stroke Association in 2019 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2018) or meet the diagnostic criteria for hemorrhagic stroke (according to the guidelines developed by the American Heart Association/American Stroke Association in 2022 and the guidelines developed by the Neurology Branch of the Chinese Medical Association in 2019) ，with lesions located in the left hemisphere, and a duration of illness ranging from 15 days to 6 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 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

DEVICEactive continuous Theta Burst Stimulation

Each patient will receive a combination of stimulation sequences, including a 600-pulse cTBS targeting at the right IFG, followed by a 600-pulse cTBS targeting at the right STG, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.

DEVICEsham continuous Theta Burst Stimulation

Each patient will receive a combination of stimulation sequences, including a 600-pulse sham cTBS targeting at the right IFG, followed by a 600-pulse sham cTBS targeting at the right STG, which will be repeated once more (a total of 2400 pulses daily). Each patient will receive a 3-week treatment period, consisting of 5 consecutive workdays each week.