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

Launched by CHANGPING LABORATORY · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients who have difficulty speaking, known as aphasia, after having a stroke. The treatment involves a technique called continuous Theta Burst Stimulation (cTBS), which uses magnetic pulses to help improve language function. The goal is to see if this method is safe and effective for helping people recover their ability to communicate after a stroke that affects the left side of the brain. The trial is currently recruiting participants aged 35 to 75 who had their first stroke at least 15 days ago but less than 3 months ago and had normal language skills before the stroke.

To be eligible, participants should be native Mandarin speakers with at least six years of education and must understand the study well enough to give their consent. They should not have any serious speech difficulties or other major health issues that could interfere with the trial. If someone joins the trial, they can expect to receive the cTBS treatment guided by advanced brain mapping technology. This trial aims to provide new hope for patients struggling with communication after a stroke, and it is important to note that participants will be closely monitored for their safety throughout the study.

Gender

ALL

Eligibility criteria

• 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.