An Open Label, One Arm, Dose Escalation Study to Evaluate The Safety of Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

There is great interest on the development of novel therapies for acute ischemic stroke, because, to date, thrombolysis is the only approved treatment. Recent evidence suggests that Extremely Low Frequency Magnetic Fields (ELF-MF) could represent an alternative approach for acute ischemic stroke therapy, because of their effects on the main mechanisms of brain ischemic damage and regeneration. Main purpose of this open label, one arm, dose escalation study is the validation of ELF-MF stimulation as non-invasive and safe tool to promote recovery in acute ischemic stroke patients. Nine patients will be treated daily for 5 consecutive days, starting within 48 hours 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 duration-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 after 1-year follow-up. Change from baseline of clinical and radiological scores will be taken as secondary outcomes. This study aims at establishing the safety and tolerability of the ELF-MF stimulation in acute ischemic stroke.