Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

Study Overview
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Brief Summary
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There is great interest in the development of novel therapies for acute ischemic stroke because, to date, the thrombolysis is the only approved treatment. Recent evidence suggests that extremely low frequency magnetic fields (ELF-MF) could be an alternative approach for acute ischemic stroke therapy because of their effects on the main mechanisms of brain ischemic damage and regeneration.The main purpose of this open label, one arm, dose escalation study is the validation of ELF-MF stimulation as non-invasive, safe and effective tool to promote recovery in acute ischemic stroke patients Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF (75 Hz, 1,8 mT) at increasing daily exposure (45, 120, 240 min).The primary outcome (safety endpoint) will be evaluated by the incidence of adverse events and mortality throughout the stimulation period and the 1-year follow-up. Secondary outcomes will consist in change from baseline in clinical and radiological scores.

Official Title
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An Open Label, One Arm, Dose Escalation Study to Evaluate the Safety of Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke.

Conditions
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Stroke

Intervention / Treatment
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* Device: pulsed ELF-MF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males or females, aged over 18 evidence of mono-hemispheric ischemic stroke confirmed by brain MRI first onset stroke patients onset of symptoms within 48 hours prior to enrollment National Institutes of Health Stroke Scale (NIHSS) score greater than 4 patient is alert, medically stable according to the treating physician and able to follow simple verbal commands signed written informed consent prior to entry into the study Exclusion Criteria: acute intracranial hemorrhage confirmed by brain CT or MRI scan previous ischemic or hemorrhagic stroke seizure at the onset of stroke or a history of epilepsy contraindications to transcranial magnetic stimulation: implanted metallic parts of implanted electronic devices, including pacemakers,defibrillators, implanted medication pump, or implanted brain stimulator aneurysm clip or other metal in body life expectancy less than 3 months other serious illness, e.g., severe hepatic, cardiac, or renal failure, acute myocardial infarction, or complex disease that may confound treatment assessment women known to be pregnant, lactating or having a positive or indeterminate pregnancy test any condition that would prevent the subject from giving voluntary informed consent current participation in another study with an investigational drug or device

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pulsed ELF-MF<br>Nine patients will be treated daily for 5 consecutive days, starting within 48 h from the onset of stroke. Three dose cohorts of three patients each, will be stimulated with pulsed ELF-MF at increasing daily exposure (45, 120, 240 min). | Device: pulsed ELF-MF<br>* (75 Hz, 1,8 mT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | The primary outcome will be evaluated by the incidence of adverse events (AEs), severe AEs (SAEs) and mortality throughout the stimulation period and the 1-year follow-up. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in National Institutes of Health Stroke Scale (NIHSS) score | NIHSS is a validated scale from 1-42 to evaluate stroke severity | Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment | 
| Change in Modified Rankin Scale (mRS) score | mRS is a straightforward evaluation of the functional limitations from stroke | Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment | 
| Change in Barthel Index (BI) | BI is a reliable disability profile scale from 0 to 15 to evaluate a patient's self-care abilities in 10 areas, including bowel and bladder control | Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment | 
| Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI | ΔILV is defined as ILV measured by FLAIR sequence at 30 days after pulsed ELF-MF treatment minus the initial ILV measured by diffusion-weighted imaging (DWI) trace sequence before pulsed ELF-MF treatment. | Baseline; 30 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Stroke, Brain Ischemia, Extremely Low Frequency Magnetic Fields