NCT05907031 pBFS-guided cTBS Over the Inferior Frontal Gyrus for Aphasia After Ischemic Stroke
| NCT ID | NCT05907031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changping Laboratory |
| Condition | Stroke, Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-23 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-08-23 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this trial is to evaluate the effectiveness and safeness of continuous Theta Burst Stimulation (cTBS) over the right Inferior Frontal Gyrus (IFG), guided by personalized Brain Functional Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.
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.
Contact & Investigator
Hesheng Liu, PhD
STUDY CHAIR
Changping Laboratory
Frequently Asked Questions
Who can join the NCT05907031 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 75 Years, studying Stroke, Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05907031 currently recruiting?
Yes, NCT05907031 is actively recruiting participants. Contact the research team at jianting.huang@pku.edu.cn for enrollment information.
Where is the NCT05907031 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT05907031 clinical trial?
NCT05907031 is sponsored by Changping Laboratory. The principal investigator is Hesheng Liu, PhD at Changping Laboratory. The trial plans to enroll 30 participants.
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