Extremely Low Frequency Magnetic Fields in Acute Ischemic Stroke

NCT01941147 | Unknown

• 1 other identifier: ELF-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Acute Stroke; Brain Ischemia; Extremely Low Frequency Magnetic Fields

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in National Institutes of Health Stroke Scale (NIHSS) score

  Baseline; immediately, 30, 90, and 365 days after pulsed ELF-MF treatment

• Change in Modified Rankin Scale (mRS) score

  Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment

• Change in Barthel Index (BI)

  Baseline;immediately, 30, 90, and 365 days after pulsed ELF-MF treatment

• Change (Δ)in ischemic lesion volume (ILV) determined by brain MRI

  Baseline; 30 days.

Study Arms (1)

Pulsed ELF-MF

EXPERIMENTAL

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

Interventions

pulsed ELF-MF DEVICE

(75 Hz, 1,8 mT)

Pulsed ELF-MF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Institute of Neurology, Campus Biomedico University

Rome, 00128, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 23428499 BACKGROUND

• 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.

  PMID: 19189041 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vincenzo Di Lazzaro, MD

  Institute of Neurology, Campus Biomedico University of Rome

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincenzo Di Lazzaro, MD

CONTACT

+39 06 22541 1320; v.dilazzaro@unicampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Chair of Neurology Department

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 13, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

IT (1)