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

Campus Bio-Medico University of Rome

Status: Terminated

Conditions: Ischemic Stroke; Stroke, Acute

Treatments: Device: SHAM Pulsed ELF-MF stimulation; Device: REAL Pulsed ELF-MF stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02767778

I-NIC

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups

REAL Pulsed ELF-MF stimulation

Experimental group

Description:

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

Treatment:

Device: REAL Pulsed ELF-MF stimulation

SHAM Pulsed ELF-MF stimulation

Sham Comparator group

Description:

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

Treatment:

Device: SHAM Pulsed ELF-MF stimulation