pBFS-guided Dual-target cTBS for Aphasia After Stroke

Launched by CHANGPING LABORATORY · Jul 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who have had a stroke and are experiencing aphasia, which is a condition that affects language skills. The researchers want to see if a personalized brain stimulation technique, called continuous theta burst stimulation (cTBS), can help improve language function. This treatment targets specific areas of the brain responsible for language and is guided by advanced technology that customizes the approach for each patient.

To be eligible for this study, participants need to be between 35 and 75 years old and must have experienced their first stroke within the last 15 days to 6 months. They should have normal language abilities before the stroke and have been diagnosed with aphasia. Participants will be carefully monitored throughout the trial for safety and effectiveness. It’s important to note that certain medical conditions, such as severe mental health issues or implanted devices, may exclude individuals from participating. Overall, this trial aims to explore a potential new way to help stroke survivors regain their ability to communicate.

Gender

ALL

Eligibility criteria

• 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 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 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, 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.