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

NCT ID: NCT02767778

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2023-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

REAL Pulsed ELF-MF stimulation

Patients will receive REAL pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.

Group Type: EXPERIMENTAL

REAL Pulsed ELF-MF stimulation

Intervention Type: DEVICE

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.

SHAM Pulsed ELF-MF stimulation

Patients will receive SHAM pulsed ELF-MF stimulation and the standard of care for acute ischemic stroke, according to current guidelines.

Group Type: SHAM_COMPARATOR

SHAM Pulsed ELF-MF stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• first onset, mono-hemispheric ischemic stroke in the middle cerebral artery territory;
• onset of symptoms within 48 hours;
• National Institutes of Health Stroke Scale (NIHSS) score between 4 and 25;
• signed written informed consent.

Exclusion Criteria

• acute intracranial hemorrhage;
• previous ischemic or hemorrhagic stroke;
• lacunar stroke, defined as not involving the cortex and < 2.0 cm if measured on MRI diffusion-weighted images;
• contraindications to transcranial magnetic stimulation such as implanted metallic parts of implanted electronic devices or other metal in body;
• historical modified Rankin Scale (mRS) >1;
• other serious or complex disease that may confound treatment assessment;
• women known to be pregnant, lactating or having a positive or indeterminate pregnancy test;
• current participation in another study.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuovo Ospedale Civile S.Agostino Estense

OTHER

Sponsor Role: collaborator

San Raffaele University Hospital, Italy

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: collaborator

Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role: collaborator

University of Rome Tor Vergata

OTHER

Sponsor Role: collaborator

Ospedale Sant'Eugenio di Roma, Italy

UNKNOWN

Sponsor Role: collaborator

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Di Lazzaro Vincenzo

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vincenzo Di Lazzaro, MD

Role: STUDY_DIRECTOR

Institute of Neurology, Campus Biomedico University

Locations

Institute of Neurology, Campus Biomedico University

Rome, , Italy

Countries

Italy

Other Identifiers

I-NIC

Identifier Type: -

Identifier Source: org_study_id