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.
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 thrombolysis and/or endovascular therapy, the time from stroke onset to the start of study intervention was less than 48-hours. Enrolled patients were randomly assigned in a 1:1 ratio to either the"LF-rTMS group" or the"Control group" to receive: 1. LF-rTMS group: 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). 2. Control group: received routine treatment. All the above therapeutic interventions were conducted by trained TMS operators. Except for the study intervention, the subjects in both groups received clinical routine diagnosis and treatment which were not affected by the intervention. All patients were followed up until the 90th day after randomization 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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).
Beijing Tian tan Hospital
Beijing, Beijing Municipality, China
Infarct growth from baseline to Day 3 (mL)
Infarct growth at 3 days was calculated as the absolute difference between the baseline core infarct volume and the 3 days post-randomization infarct volume. Positive values indicate infarct growth.
Time frame: 3 days
Symptomatic intracranial hemorrhage
The proportion of symptomatic intracranial hemorrhage
Time frame: 3 days
Proportion of Early neurological improvement (ENI)
Proportion of patients with a reduction of ≥4 on the NIHSS, compared with the baseline score or an NIHSS of 0 or 1
Time frame: 3 days
Final infarct volume at Day 3 (mL)
Final infarct volume, in milliliters, measured 3 days after randomization.
Time frame: 3 days
Change in NIHSS score from baseline to Day 3
Change in NIHSS score from baseline to Day 3
Time frame: 3 days
Proportion of participants with modified Rankin Scale score 0 to 1 at Day 90
Proportion of participants with modified Rankin Scale score 0 to 1 at Day 90
Time frame: 90 days
Proportion of participants with modified Rankin Scale score 0 to 2 at Day 90
Proportion of participants with modified Rankin Scale score 0 to 2 at Day 90
Time frame: 90 days
Barthel index of ADL
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Barthel index of ADL, 0-100 (better)
Time frame: 90 days
EQ-5D-5L
The Health Questionnaire (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "no problems" through "extreme problems."
Time frame: 90 days
Montreal Cognitive Assessment (MoCA) total score
Total score of the MoCA Performance on the MoCA (0-30; higher score indicates better performance)
Time frame: 90 days
Number of participants with neurological deterioration within 3 days
The incidence of deterioration of neurological function (NIHSS increase ≥4 points)
Time frame: 3 days
Number of participants with symptomatic intracranial hemorrhage within 90 days
Number of participants with symptomatic intracranial hemorrhage within 90 days
Time frame: 90 days
All-cause deaths
The proportion of all-cause deaths
Time frame: 90 days
Stroke recurrence
Recurrence rate of symptomatic stroke (cerebral infarction, cerebral hemorrhage)
Time frame: 90 days
Serious adverse events
The proportion of serious adverse events (SAE)
Time frame: 90 days
Adverse events (AE)
The proportion of adverse events (AE)
Time frame: 90 days