Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours (NCT06064734) | Clinical Trial Compass
CompletedNot Applicable
Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours
China60 participantsStarted 2024-03-11
Plain-language summary
This is a multicenter, open-label, evaluator-blinded, investigator-initiated, randomized clinical trial, to evaluate the clinical efficacy and safety of LF-rTMS in reducing infarct size, reducing disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18-80 years, gender is not limited;
✓. Acute ischemic stroke of anterior circulation was diagnosed clinically
✓. mRS 0-1 score before onset;
✓. 6 ≤ NIHSS ≤25 at randomization;
✓. Within 48 hours of stroke onset;
✓. No thrombolysis therapy or thrombectomy is planned;
✓. Obtain informed consent signed by the patient himself or by his legal authorized representative.
Exclusion criteria
✕. TMS contraindications include metallic foreign bodies in the head, pacemaker, implantable drug pumps, cochlear implants, etc.
✕. Epilepsy or history of epilepsy, intracranial hypertension, tumor and other serious neurological disorders;
✕. Midline displacement and brain parenchymal mass effect seen in head CT and other images;
✕. Head CT or MRI showed bilateral acute cerebral infarction, brainstem infarction, or insular infarction;
✕. Evidence of acute intracranial hemorrhage;
✕. A history of congenital or acquired hemorrhagic disease, coagulation factor deficiency, or thrombocytopenia disease;
. After blood pressure control, the systolic blood pressure was still ≥180 mmHg or the diastolic blood pressure was ≥110 mmHg;
✕. Known recent or current serum creatinine exceeding 1.5 times the upper limit of normal or estimated glomerular filtration rate (EGFR) \< 60 mL/min;