Low-Frequency REpetitive TRanscranial Magnetic Stimulation in ACute Ischemic StrokE Within 48 Hours (RETRACE-I): A Randomized, Open-label, Evaluator-blinded, Phase 2 Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of Early neurological improvement (ENI)
研究概览
简要总结
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.
详细描述
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:
- 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).
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The investigators involved in the clinical evaluation of the patients remained blinded to treatment grouping.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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, brainstem infarction, or 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.
研究组 & 干预措施
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).
干预措施: LF-rTMS (Device)
Control
Routine treatment.
结局指标
主要结局
Proportion of Early neurological improvement (ENI)
时间窗: 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
时间窗: 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
时间窗: 3 days
The proportion of symptomatic intracranial hemorrhage
Infarct growth from baseline to Day 3 (mL)
时间窗: 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. Positive values indicate infarct growth.
次要结局
- mRS scores of 0-1(90 days)
- Final infarct volume(3 days)
- mRS scores of 0-2(90 days)
- Barthel index of ADL(90 days)
- Montreal Cognitive Assessment (MoCA) total score(90 days)
- All-cause deaths(90 days)
- Stroke recurrence(90 days)
- △NIHSS score(3 days)
- Serious adverse events(90 days)
- Symptomatic intracranial hemorrhage(90 days)
- Deterioration of neurological function(3 days)
- Adverse events (AE)(90 days)
- EQ-5D-5L(90 days)
- Proportion of Early neurological improvement (ENI)(3 days)
- Final infarct volume at Day 3 (mL)(3 days)
- Change in NIHSS score from baseline to Day 3(3 days)
- Proportion of participants with modified Rankin Scale score 0 to 1 at Day 90(90 days)
- Proportion of participants with modified Rankin Scale score 0 to 2 at Day 90(90 days)
- Number of participants with neurological deterioration within 3 days(3 days)
- Number of participants with symptomatic intracranial hemorrhage within 90 days(90 days)
研究者
Yongjun Wang
Professor
Beijing Tiantan Hospital