Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours
- Conditions
- Stroke, AcuteStroke, Ischemic
- Interventions
- Device: LF-rTMS
- Registration Number
- NCT06064734
- Lead Sponsor
- Beijing Tiantan Hospital
- 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 disability rate and improving functional outcome in patients with acute ischemic stroke within 48 hours after stroke onset.
- 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 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LF-rTMS LF-rTMS 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).
- Primary Outcome Measures
Name Time Method Proportion of Early neurological improvement (ENI) 3 days Proportion of patients with a reduction of ≥4 on the NIHSS, compared with the baseline score or an NIHSS of 0 or 1
Infarct growth 3 days 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.
Symptomatic intracranial hemorrhage 3 days The proportion of symptomatic intracranial hemorrhage
- Secondary Outcome Measures
Name Time Method mRS scores of 0-1 90 days Proportion of patients with mRS scores of 0-1
Final infarct volume 3 days Final infarct volume
mRS scores of 0-2 90 days Proportion of patients with mRS scores of 0-2
Barthel index of ADL 90 days Barthel index of ADL, 0-100 (better)
Montreal Cognitive Assessment (MoCA) total score 90 days Total score of the MoCA Performance on the MoCA (0-30; higher score indicates better performance)
All-cause deaths 90 days The proportion of all-cause deaths
Stroke recurrence 90 days Recurrence rate of symptomatic stroke (cerebral infarction, cerebral hemorrhage)
△NIHSS score 3 days Change in NIHSS score from baseline
Serious adverse events 90 days The proportion of serious adverse events (SAE)
Symptomatic intracranial hemorrhage 90 days The incidence of symptomatic intracranial hemorrhage
Deterioration of neurological function 3 days The incidence of deterioration of neurological function (NIHSS increase ≥4 points)
Adverse events (AE) 90 days The proportion of adverse events (AE)
EQ-5D-5L 90 days 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."
Trial Locations
- Locations (1)
Beijing Tian tan Hospital
🇨🇳Beijing, Beijing, China