Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Device: pulsed ELF-MF

• Registration Number: NCT01941147
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Status Verified: 2013-09
• Study First Submitted: 2013-09-09
• Study First Submitted QC: 2013-09-09
• Last Update Submitted: 2013-09-09
• Study First Posted: 2013-09-13
• Last Update Posted: 2013-09-13
• Primary Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulsed ELF-MF	pulsed ELF-MF	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).

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Change in National Institutes of Health Stroke Scale (NIHSS) score	Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment	NIHSS is a validated scale from 1-42 to evaluate stroke severity
Change in Modified Rankin Scale (mRS) score	Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment	mRS is a straightforward evaluation of the functional limitations from stroke
Change in Barthel Index (BI)	Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment	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
Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI	Baseline; 30 days.	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.

Trial Locations

Locations (1)

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