An Open Label, One Arm, Dose Escalation Study to Evaluate the Safety of Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
There is great interest in the development of novel therapies for acute ischemic stroke because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for acute ischemic stroke therapy because of their effects on the main mechanisms of brain ischemic damage and regeneration.The main purpose of this open label, one arm, dose escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective tool to promote recovery in acute ischemic stroke patients Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be evaluated by the incidence of adverse events and mortality throughout the stimulation period and the 1-year follow-up. Secondary outcomes will consist in change from baseline in clinical and radiological scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males or females, aged over 18
- •evidence of mono-hemispheric ischemic stroke confirmed by brain MRI
- •first onset stroke patients
- •onset of symptoms within 48 hours prior to enrollment
- •National Institutes of Health Stroke Scale (NIHSS) score greater than 4
- •patient is alert, medically stable according to the treating physician and able to follow simple verbal commands
- •signed written informed consent prior to entry into the study
排除标准
- •acute intracranial hemorrhage confirmed by brain CT or MRI scan
- •previous ischemic or hemorrhagic stroke
- •seizure at the onset of stroke or a history of epilepsy
- •contraindications to transcranial magnetic stimulation: implanted metallic parts of implanted electronic devices, including pacemakers,defibrillators, implanted medication pump, or implanted brain stimulator
- •aneurysm clip or other metal in body
- •life expectancy less than 3 months
- •other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction, or complex disease that may confound treatment assessment
- •women known to be pregnant, lactating or having a positive or indeterminate pregnancy test
- •any condition that would prevent the subject from giving voluntary informed consent
- •current participation in another study with an investigational drug or device
结局指标
主要结局
Incidence of adverse events
时间窗: 1 year
The primary outcome will be evaluated by the incidence of adverse events (AEs), severe AEs (SAEs) and mortality throughout the stimulation period and the 1-year follow-up.
次要结局
- Change in National Institutes of Health Stroke Scale (NIHSS) score(Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment)
- Change in Modified Rankin Scale (mRS) score(Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment)
- Change in Barthel Index (BI)(Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment)
- Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI(Baseline; 30 days.)
研究者
Di Lazzaro Vincenzo
Professor - Chair of Neurology Department
Campus Bio-Medico University