NCT05999318 pBFS-guided cTBS Over the Superior Temporal Gyrus for Aphasia After Ischemic Stroke
| NCT ID | NCT05999318 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Changping Laboratory |
| Condition | Stroke, Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-11-07 |
| Primary Completion | 2025-08-20 |
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 40 participants in total. It began in 2023-11-07 with a primary completion date of 2025-08-20.
⚠ 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 Superior Temporal Gyrus (STG), guided by personalized Brain Function Sector (pBFS) technology, on language function recovery in patients with post-ischemic stroke aphasia.
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 acute ischemic stroke (diagnosed according to the "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" written by the American Heart Association/American Stroke Association in 2019 and the "Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2018" compiled by the Neurology Branch of the Chinese Medical Association in 2018), with lesions in the left hemisphere, a duration of ≥15 days and ≤3 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 severe 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.
Contact & Investigator
Hesheng Liu, PhD
STUDY CHAIR
Changping Laboratory
Frequently Asked Questions
Who can join the NCT05999318 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 NCT05999318 currently recruiting?
Yes, NCT05999318 is actively recruiting participants. Contact the research team at naxu@cpl.ac.cn for enrollment information.
Where is the NCT05999318 trial being conducted?
This trial is being conducted at Changchun, China, Shenyang, China.
Who is sponsoring the NCT05999318 clinical trial?
NCT05999318 is sponsored by Changping Laboratory. The principal investigator is Hesheng Liu, PhD at Changping Laboratory. The trial plans to enroll 40 participants.
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