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

NCT02767778 | Terminated DMC

• 1 other identifier: I-NIC
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

Acute ischemic stroke; Neuroprotection; Extremely low frequency magnetic fields

Outcome Measures

Primary Outcomes (1)

• Change in the volume of the ischemic lesion measured by MRI

  The effect of pulsed ELF-MF on ischemic lesion volume will be evaluated by MR at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7 and 45 days from the onset of the stroke).

  Baseline and 45 days

Secondary Outcomes (10)

• Change in NIHSS score

  Baseline and 90 days

• Change in mRS score

  Baseline and 90 days

• Change in Barthel Index score

  Baseline and 90 days

• Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.

  90 days

• Number of participants with abnormal vital parameters.

  5 days

Study Arms (2)

REAL Pulsed ELF-MF stimulation

EXPERIMENTAL

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

Device: REAL Pulsed ELF-MF stimulation

SHAM Pulsed ELF-MF stimulation

SHAM COMPARATOR

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

Device: SHAM Pulsed ELF-MF stimulation

Interventions

REAL Pulsed ELF-MF stimulation 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.

REAL Pulsed ELF-MF stimulation

SHAM Pulsed ELF-MF stimulation 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.

SHAM Pulsed ELF-MF stimulation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead
• Nuovo Ospedale Civile S.Agostino Estense: collaborator
• San Raffaele University Hospital, Italy: collaborator
• University Hospital of Ferrara: collaborator
• Azienda USL Reggio Emilia - IRCCS: collaborator
• University of Rome Tor Vergata: collaborator
• Ospedale Sant'Eugenio di Roma, Italy: collaborator

Study Sites (1)

Institute of Neurology, Campus Biomedico University

Rome, 00128, Italy

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vincenzo Di Lazzaro, MD

  Institute of Neurology, Campus Biomedico University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 10, 2016
• Study Start: April 1, 2016
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: October 25, 2023

Record last verified: 2023-10

Locations

IT (1)