Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke

Launched by XIJING HOSPITAL · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a treatment called continuous theta-burst stimulation (cTBS) for patients who have had an acute ischemic stroke and have undergone a procedure to remove a blood clot from the brain (known as endovascular thrombectomy). The goal is to see if cTBS can help improve recovery after this type of stroke. This trial will involve several medical centers and will compare the effects of the actual treatment with a "sham" treatment (where participants receive a placebo that looks and feels like the real treatment but has no therapeutic effect).

To be eligible for this study, participants must be between 18 and 80 years old and have had a specific type of stroke caused by a blockage in certain blood vessels in the brain. Their symptoms should have started within the last 6 to 24 hours, and they need to have a certain level of stroke severity before the clot removal procedure. It’s important to note that individuals with certain medical conditions, such as those with pacemakers or severe neurological disorders, will not be eligible to participate. If selected, participants can expect to undergo the treatment, be monitored for safety, and contribute to important research that could help improve stroke recovery for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
• • 2. Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1 segment of the middle cerebral artery.
• • 3. DWI shows an infarct volume less than one-third of the MCA territory, with onset of symptoms ≤6 hours, or a head CT within 24 hours of onset indicating an ASPECT score ≥6.
• • 4. Symptom onset time is ≤6 hours or between 6-24 hours with multimodal imaging (assessment) confirming eligibility for thrombectomy.
• • 5. Pre-stroke mRS score is ≤1.
• • 6. NIHSS score before thrombectomy is between 6 and 25.
• • 7. With vascular recanalization of mTICI \> 2b/3.
• • 6. Informed consent form signed.
• Exclusion Criteria:
• • 1. Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
• • 2. Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
• • 3. Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
• • 4. Head CT/MRI suggests acute cerebral infarction in both sides;
• • 5. Patients with a history of congenital or acquired bleeding disorders, coagulation factor deficiencies, or thrombocytopenia;
• • 6. Patients with blood pressure more than 180/110 mmHg after antihypertensive treatment;
• • 7. Patients who are pregnant or breastfeeding;
• • 8. Patients with severe mental disorders or dementia who cannot cooperate with follow-up;
• • 6. Patients with other severe diseases resulting in an expected survival of less than 90 days; 7. Patients who are participating in other interventional clinical studies within 30 days before the start of this study or after the onset of this condition; 8. Patients who cannot cooperate with informed consent.