Effects of Transcranial Magnetic Stimulation After Endovascular Treatment for Acute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXijing Hospital
About this trial
This is a multicenter, randomized, double-blind, sham-controlled trial, to determine the efficacy and safety of cTBS in treating patients with acute ischemic stroke after endovascular treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with acute anterior circulation ischemic stroke aged between 18 and 80 years old.
Imaging suggests that the infarction is caused by occlusion of the terminal portion of the internal carotid artery or the M1/M2 segment of the middle cerebral artery.
A head CT within 24 hours of onset indicates an ASPECT score ≥6, and meets the guideline-recommended criteria for thrombectomy.
Pre-stroke mRS score is ≤1.
Disqualifiers
Patients with contraindications to TMS treatment, such as those with metallic foreign objects in the head, pacemakers, implantable drug pumps, cochlear implants, etc.;
Patients with epilepsy, increased intracranial pressure, tumors, acute cerebral hemorrhage, or other severe neurological diseases, and those with severe functional impairment of organs such as the heart, liver, and kidneys;
Head CT/MRI indicates midline shift or significant mass effect, or patients planned for surgical intervention;
Head CT/MRI suggests acute cerebral infarction in both sides;
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation Active
DeviceThe patients will be treated with cTBS and usual medical treatment after endovascular treatment
Transcranial Magnetic Stimulation Sham
DeviceThe patients will be treated with sham-cTBS and usual medical treatment after endovascular treatment
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active-cTBS groupExperimental treatment 1 intervention
Group B: Sham-cTBS groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes of infarct volumes from baseline to Day 5
Time frame
5 days after enrollment2
Death
Time frame
The first 5 days after enrollment3
NIHSS at Day 5
Time frame
5 days after enrollmentSecondary outcomes
1
Early neurological deterioration
proportion of patients with an increase of ≥4 points in NIHSS at 3 days
Time frame
3 days after enrollment2
Final infarct volume
The infarct volume on DWI at 5 days
Time frame
5 days after enrollment3
Intracranial hemorrhage incidence
Time frame
24h after enrollment4
Proportion of patients with symptomatic intracranial hemorrhage
Time frame
90 days after enrollmentSponsors and contacts
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Source ClinicalTrials.gov