Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: pulsed ELF-MF

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincenzo Di Lazzaro, MD; Phone Number: +39 06 22541 1320; Email: v.dilazzaro@unicampus.it

Study Locations

• Italy
  • Rome, Italy, 00128
    • Recruiting
    • Institute of Neurology, Campus Biomedico University
    • Contact: Vincenzo Di Lazzaro, MD; Phone Number: +39 06 22541 1320; Email: v.dilazzaro@unicampus.it
    • Principal Investigator: Fioravante Capone, MD
    • Sub-Investigator: Marzia Corbetto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: pulsed ELF-MF; (75 Hz, 1,8 mT)

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University
• Investigators: Principal Investigator: Vincenzo Di Lazzaro, MD, Institute of Neurology, Campus Biomedico University of Rome

Publications and helpful links

General Publications

• Di Lazzaro V, Capone F, Apollonio F, Borea PA, Cadossi R, Fassina L, Grassi C, Liberti M, Paffi A, Parazzini M, Varani K, Ravazzani P. A consensus panel review of central nervous system effects of the exposure to low-intensity extremely low-frequency magnetic fields. Brain Stimul. 2013 Jul;6(4):469-76. doi: 10.1016/j.brs.2013.01.004. Epub 2013 Feb 4.
• Capone F, Dileone M, Profice P, Pilato F, Musumeci G, Minicuci G, Ranieri F, Cadossi R, Setti S, Tonali PA, Di Lazzaro V. Does exposure to extremely low frequency magnetic fields produce functional changes in human brain? J Neural Transm (Vienna). 2009 Mar;116(3):257-65. doi: 10.1007/s00702-009-0184-2. Epub 2009 Feb 3.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 13, 2013

Study Record Updates

• Last Update Posted (Estimate): September 13, 2013
• Last Update Submitted That Met QC Criteria: September 9, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Acute Stroke; Brain Ischemia; Extremely Low Frequency Magnetic Fields
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: ELF-01