Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours (RETRACE-I)
Stroke, Acute, Stroke, Ischemic
About this trial
This is an interventional treatment trial for Stroke, Acute focused on measuring Acute Ischemic Stroke, LF-rTMS, Phase 2 Pilot Trial
Eligibility Criteria
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 and involved 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; Patients during pregnancy or lactation and within 90 days of planned pregnancy; Patients with severe mental disorders or dementia who can not cooperate with informed consent and follow-up; Patients with malignancy or severe systemic disease and expected survival of less than 90 days; Participants in other clinical intervention studies within 30 days before randomization or who were participating in other clinical intervention studies.
Sites / Locations
- Beijing Tian tan Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
LF-rTMS
Control
H 4 Coil (stimulation site: prefrontal cortex, insular lobe),1-Hz rTMS, stimulation intensity RMT 100%,1200 pulses/session, two sessions (2400 pulses)/day (interval ≥2 hours), lasting about half an hour each time, the total duration of treatment was 3 days (6 sessions,7200 pulses).
Routine treatment.