pBFS-guided cTBS at Different Doses for Aphasia After Stroke

Launched by CHANGPING LABORATORY · Jul 23, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach to help people recover their language skills after having a stroke, specifically those who have developed a condition called aphasia, which makes it difficult to speak or understand language. The researchers are testing different doses of a therapy called continuous Theta Burst Stimulation (cTBS), which is applied to a specific area of the brain known to be involved in language. This treatment is guided by a personalized technology that aims to tailor the therapy to each individual’s brain function.

To participate in this trial, individuals must be between 35 and 75 years old and have had their first stroke within the last 15 days to 6 months, with specific language challenges as assessed by a standard test. Participants should have had normal language skills before their stroke and speak Chinese. If someone joins the study, they will receive the cTBS treatment and be monitored for its effects on their language recovery. It’s important to note that there are certain health conditions and situations that would make someone ineligible for this trial, such as having other serious medical issues or a history of seizures.

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.