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

Not Applicable

Terminated

• Conditions: Ischemic Stroke; Stroke, Acute
• Interventions: Device: REAL Pulsed ELF-MF stimulation; Device: SHAM Pulsed ELF-MF stimulation

• Registration Number: NCT02767778
• Lead Sponsor: Campus Bio-Medico University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-05-08
• Study First Posted: 2016-05-10
• Primary Completion: 2023-08
• Study Completion: 2023-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REAL Pulsed ELF-MF stimulation	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.
SHAM Pulsed ELF-MF stimulation	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.

Primary Outcome Measures

Name	Time	Method
Change in the volume of the ischemic lesion measured by MRI	Baseline and 45 days	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).

Secondary Outcome Measures

Name	Time	Method
Number of patients requiring to stop treatment sessions	90 days
Change in NIHSS score	Baseline and 90 days	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.
Incidence of adverse events (AEs) and severe AEs (SAEs) that are related to treatment.	90 days	Safety will be assessed by measuring the incidence of AEs and SAEs throughout the stimulation period and along 3-months follow-up.
Number of participants with hemorrhagic transformation of ischemic lesion at MRI .	7 days
Incidence of mortality	90 days	Safety will be assessed by measuring the incidence of mortality throughout the stimulation period and along 3-months follow-up.
Change in Barthel Index score	Baseline and 90 days	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.
Change in mRS score	Baseline and 90 days	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.
Number of participants with abnormal vital parameters.	5 days	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).
Change in NIHSS score during the 5-days ELF-MF exposure period.	5 days	Early neurological worsening will be evaluated by change in NIHSS score during the 5-days ELF-MF exposure period.
Incidence of discomfort during treatment sessions	90 days	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.

Trial Locations

Locations (1)

Institute of Neurology, Campus Biomedico University; 🇮🇹 Rome, Italy