Low-frequency Pulsed Electromagnetic Fields (ELF-MF) as Treatment for Acute Ischemic Stroke "I-NIC"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

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

Sponsors