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

Summary

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

• Stroke, Acute
• Ischemic Stroke

Interventions

DEVICE

REAL Pulsed ELF-MF stimulation

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.

DEVICE

SHAM Pulsed ELF-MF stimulation

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.

Sponsors & Collaborators

• Nuovo Ospedale Civile S.Agostino Estense

  collaborator OTHER

• San Raffaele University Hospital, Italy

  collaborator OTHER

• University Hospital of Ferrara

  collaborator OTHER

• Azienda USL Reggio Emilia - IRCCS

  collaborator OTHER_GOV

• University of Rome Tor Vergata

  collaborator OTHER

• Ospedale Sant'Eugenio di Roma, Italy

  collaborator UNKNOWN

• Campus Bio-Medico University

  lead OTHER

Principal Investigators

• Vincenzo Di Lazzaro, MD · Institute of Neurology, Campus Biomedico University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2023-08-31

Completion

2023-08-31

Countries

• Italy

Study Locations