Status:
UNKNOWN
Low-Frequency REpetitive TRanscranial Magnetic Stimulation Combined With Endovascular Treatment in ACute Ischemic StrokE
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Stroke, Acute Ischemic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a multicenter, randomized, double-blind, sham-controlled, investigator-initiated clinical study, to evaluate the clinical efficacy and safety of LF-rTMS in rescuing the ischemic penumbra, redu...
Detailed Description
The target population of this study was patients with acute ischemic stroke of the anterior circulation diagnosed clinically. The site of acute occlusion of the responsible vessel was located in the i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06064747
Start Date
October 8 2023
End Date
October 30 2024
Last Update
October 3 2023
Active Locations (1)
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1
Beijing Tian tan Hospital
Beijing, Beijing Municipality, China, 100070