Low-Frequency REpetitive TRanscranial Magnetic Stimulation Combined With Endovascular Treatment in ACute Ischemic StrokE (RETRACE-II)
Stroke, Acute Ischemic
About this trial
This is an interventional treatment trial for Stroke, Acute Ischemic focused on measuring Acute ischemic stroke, LF-rTMS, Endovascular therapy, Phase 2 Pilot Trial
Eligibility Criteria
Inclusion Criteria: 18 - 80 years, male or female; Clinically diagnosed as acute anterior ischemic stroke, artery occlusion occurred at the terminal of the intracranial carotid artery, T-shaped bifurcation or M1 segment of the middle cerebral artery; Within 24 hours of stroke onset; Eligible for other imaging indications for bridging therapy or direct mechanical thrombectomy: ASPECTS ≥6 certified by the latest brain CT imaging; Patients within 6-16 hours after stroke onset should meet the mismatch criteria, which was defined as infarction core volume <70 ml, mismatch ratio ≥1.8 and the ischemic volume > 15 ml (DEFUSE-3 Criteria); or NIHSS score ≥ 10 with infarction -core volume < 31 cm3, or NIHSS score ≥ 20 with infarction core volume ≤ 51 cm3 (DAWN Criteria); Patients within 16-24 hours after stroke onset should meet the mismatch criteria, which was defined as NIHSS score ≥ 10 with infarction-core volume < 31 cm3, or NIHSS score ≥ 20 with infarction-core volume ≤ 51 cm3 (DAWN Criteria); Planned to receive bridging therapy (endovascular therapy after intravenous alteplase) or direct endovascular therapy; Pre-morbid modified Rankin Scale ≤1; 6 ≤ NIHSS ≤ 25 before endovascular therapy; Signed informed consent from subjects or legally authorized representatives 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; CT or MRI showed a large area of infarction (> 1/3 of the area supplied by middle cerebral artery); Evidence of acute intracranial hemorrhage; Before the bridging therapy, other thrombolytic drugs besides alteplase or tenecteplase were used; 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
Sham Comparator
LF-rTMS
Sham coil stimulation
Using "8" coil,1-Hz rTMS to stimulate the M1 region of the ipsilateral hemisphere, the stimulation intensity was RMT 100%, 1200pulses/session, two sessions (2400 pulses)/day (interval ≥ 2 hours), lasting 3 days (total 6 sessions, 7200pulses)
The sham stimulation coil was used to stimulate the same site, duration and sound as the LF-rTMS group, ensuring no effective stimulation, twice a day for 3 days