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

Ischemic Stroke Clinical Trial

— I-NIC  

Official title:

A Multicentric, Prospective, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Effectiveness of Low-frequency Pulsed Electromagnetic Fields (ELF-MF) in Acute Ischemic Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02767778
• Other study ID #: I-NIC
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 2023

Study information

• Verified date: October 2023
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Institute of Neurology, Campus Biomedico University	Rome

Sponsors (7)

Lead Sponsor	Collaborator
Campus Bio-Medico University	Arcispedale Santa Maria Nuova-IRCCS, Nuovo Ospedale Civile S.Agostino Estense, Ospedale Sant'Eugenio di Roma, Italy, San Raffaele University Hospital, Italy, University Hospital of Ferrara, University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in NIHSS score	Clinical evaluations will be performed by means of international well-validated scales (NIHSS) at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7, 45 and 90 days from the onset of the stroke). Clinical outcome measure is the change from baseline in NIHSS score measured at different follow-up after pulsed ELF-MF exposure.	Baseline and 90 days
Secondary	Change in mRS score	Clinical evaluations will be performed by means of international well-validated scales (mRS) at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7, 45 and 90 days from the onset of the stroke). Clinical outcome measure is the change from baseline in mRS score measured at different follow-up after pulsed ELF-MF exposure.	Baseline and 90 days
Secondary	Change in Barthel Index score	Clinical evaluations will be performed by means of international well-validated scales (Barthel Index) at baseline (within 48 hours from the onset of the stroke), and after the 5-days ELF-MF exposure (after 7, 45 and 90 days from the onset of the stroke). Clinical outcome measure is the change from baseline in Barthel Index scores measured at different follow-up after pulsed ELF-MF exposure.	Baseline and 90 days
Secondary	Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.	Safety will be assessed by measuring the incidence of AEs and SAEs throughout the stimulation period and along 3-months follow-up.	90 days
Secondary	Number of participants with abnormal vital parameters.	During the pulsed ELF-MF stimulation, patients will be continuously monitored by multimodal monitor that simultaneously measures and displays the relevant vital parameters (respiratory rate, heart rate, blood pressure, pulse oximetry).	5 days
Secondary	Change in NIHSS score during the 5-days ELF-MF exposure period.	Early neurological worsening will be evaluated by change in NIHSS score during the 5-days ELF-MF exposure period.	5 days
Secondary	Number of participants with hemorrhagic transformation of ischemic lesion at MRI .		7 days
Secondary	Incidence of mortality	Safety will be assessed by measuring the incidence of mortality throughout the stimulation period and along 3-months follow-up.	90 days
Secondary	Number of patients requiring to stop treatment sessions		90 days
Secondary	Incidence of discomfort during treatment sessions	Ad hoc questionnaire to detect any discomfort created by ELF-MF stimulation (e.g. nausea, headache, palpitations, anxiety, sweating) will be administered daily during the whole hospital stay and, after the discharge, at each outward control.	90 days