Status:
UNKNOWN
Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Stroke, Acute
Stroke, Ischemic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 disa...
Detailed Description
The target population of this study was patients with clinically diagnosed AIS who had an acute occlusion of the responsible vessel in the anterior circulation and were not scheduled for intravenous t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06064734
Start Date
October 28 2023
End Date
October 30 2024
Last Update
October 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Beijing Tian tan Hospital
Beijing, Beijing Municipality, China, 100070