Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01941147
• Other study ID #: ELF-01
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2013
• Last updated: September 9, 2013
• Start date: August 2013

Study information

• Verified date: September 2013
• Source: Campus Bio-Medico University
• Contact: Vincenzo Di Lazzaro, MD
• Phone: +39 06 22541 1320
• Email: v.dilazzaro[@]unicampus.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• pulsed ELF-MF
(75 Hz, 1,8 mT)

Locations

Country	Name	City	State
Italy	Institute of Neurology, Campus Biomedico University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change (?)in ischemic lesion volume (ILV) determined by brain MRI	?ILV 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.	No