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, reducing disability rate and improving functional outcome in patients with acute ischemic stroke receiving early endovascular recanalization (bridging or direct endovascular therapy)
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 intracranial segment of the internal carotid artery, T-type bifurcation or M1 segment of the middle cerebral artery, planning for bridging therapy (bridging intravascular therapy after intravenous thrombolysis with alteplase) or direct intravascular therapy, the time from stroke onset to the start of the trial intervention was less than 24 hours (when the exact time of onset was unknown, the patient's"Last apparent normal time" was defined as the time of onset). Enrolled patients were randomly assigned in a 1:1 ratio to the"LF-rTMS group" or the"Sham Stimulation Group" and received: 1. LF-rTMS group: 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); 2. Sham stimulation group: 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. All patients received endovascular therapy (bridging therapy or direct endovascular therapy). All patients were followed up until the 90th day after randomization to evaluate the clinical efficacy and safety of LF-rTMS in rescuing the ischemic penumbra, reducing disability rate and improving functional outcome in patients with acute ischemic stroke receiving early endovascular recanalization (bridging or direct endovascular therapy)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
LF-rTMS group: 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);
Sham stimulation group: 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.
Beijing Tian tan Hospital
Beijing, Beijing Municipality, China
Early neurological improvement (ENI)
The 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
Symptomatic intracranial hemorrhage
The proportion of symptomatic intracranial hemorrhage
Time frame: 3 days
Rescue penumbra ratio
Baseline penumbra volume - Infarct volume 3 days after randomization / Baseline penumbra volume × 100%
Time frame: 3 days
Infarct volume progression
The difference between CT infarct volume and baseline core infarct volume
Time frame: 3 days
Final infarct volume
Infarct volume on DWI at day 7 after randomization, and infarct volume on FlAIR at Day 90 ± 7 after randomization.
Time frame: 7 and 90 days
mRS scores of 0-1
Proportion of patients with mRS scores of 0-1
Time frame: 90 days
mRS scores of 0-2
Proportion of patients with mRS scores of 0-2
Time frame: 90 days
Serious adverse events (SAE)
The proportion of serious adverse events (SAE)
Time frame: 90 days
All-cause deaths
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The proportion of all-cause deaths
Time frame: 90 days
Symptomatic intracranial hemorrhage
The incidence of symptomatic intracranial hemorrhage
Time frame: 90 days
Deterioration of neurological function
The incidence of deterioration of neurological function (NIHSS increase ≥4 points)
Time frame: 3 days
Stroke recurrence
Cerebral infarction, cerebral hemorrhage
Time frame: 90 days
Adverse events (AE)
Adverse events (AE)
Time frame: 3 days