The main purpose of this multicentric, prospective, randomized, placebo-controlled, double-blind study is the validation of pulsed ELF-MF stimulation as non-invasive and safe tool to promote recovery in acute ischemic stroke patients.
124 patients with acute ischemic stroke will be recruited and randomly assigned to real or sham group. Patients will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT), for 120 min daily, for 5 consecutive days, starting within 48 hours from the onset of stroke.
The primary outcome will consist of reduction of the expected infarct growth at MR measured in the subacute and chronic phase. Secondary outcomes will explore clinical effectiveness, safety and tolerability of pulsed ELF-MF in acute ischemic stroke.
- REAL Pulsed ELF-MF stimulation Device
Intervention Desc: Within 48 hours from the onset of the stroke, the enrolled patients will undergo to 120 min, daily, pulsed ELF-MF treatment for 5 consecutive days, during their hospital stay.Pulsed ELF-MF stimulation will be administrated by a rectangular, flexible coil, positioned upon the ischemic hemisphere and connected to the pulse generator (B-01; IGEA, Carpi, Italy) producing a single-pulsed signal at 75±2 Hz, with a pulse duration of 1.3 ms and a peak intensity of the magnetic field of 1.8±0.2 mT. ARM 1: Kind: Experimental Label: REAL Pulsed ELF-MF stimulation Description: Patients will receive REAL pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.
- SHAM Pulsed ELF-MF stimulation Device
Intervention Desc: SHAM pulsed ELF-MF stimulation will be administrated by a rectangular, flexible coil, positioned upon the ischemic hemisphere and connected to the pulse generator (B-01; IGEA, Carpi, Italy). The device for SHAM stimulation is identical and produces the same auditory sensation of the device for REAL stimulation but the SHAM device has no stimulating effect on the brain. ARM 1: Kind: Experimental Label: SHAM Pulsed ELF-MF stimulation Description: Patients will receive SHAM pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change in the volume of the ischemic lesion measured by MRI||Baseline and 45 days||No|
|Secondary||Change in NIHSS score||Baseline and 90 days||No|
|Secondary||Change in mRS score||Baseline and 90 days||No|
|Secondary||Change in Barthel Index score||Baseline and 90 days||No|
|Secondary||Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.||90 days||Yes|
|Secondary||Number of participants with abnormal vital parameters.||5 days||Yes|
|Secondary||Change in NIHSS score during the 5-days ELF-MF exposure period.||5 days||Yes|
|Secondary||Number of participants with hemorrhagic transformation of ischemic lesion at MRI .||7 days||Yes|
|Secondary||Incidence of mortality||90 days||Yes|
|Secondary||Number of patients requiring to stop treatment sessions||90 days||Yes|
|Secondary||Incidence of discomfort during treatment sessions||90 days||Yes|